[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OLV":3},{"classification":4,"mappedDevices":154,"similarCandidates":155,"relatedClassifications":238,"syncDates":285},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":147,"updated_at":148,"recall_count":149,"latest_recall_date":150,"k510_count":151,"pma_count":152,"event_count":153},6280,"OLV","Standard Polysomnograph With Electroencephalograph","2","882.1400","NE","Neurology","1","Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and\u002For oximetry signals) for sleep recordings.  May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":83,"device_class":8,"implant_flag":144,"product_code":6,"review_panel":10,"gmp_exempt_flag":144,"third_party_flag":145,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":83,"life_sustain_support_flag":144,"medical_specialty_description":11,"summary_malfunction_reporting":146},{"k_number":17,"fei_number":82,"registration_number":131},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"K050425","K010728","K240700","K991446","K050833","K021185","K022249","K213007","K992291","K994142","K984580","K934599","K111055","K073491","K010460","K003681","K022037","K173690","K974587","K990522","K992742","K052066","K093728","K992283","K260585","K042039","K000338","K970951","K991900","K042364","K012085","K022121","K922106","K181709","K161650","K860219","K001013","K971813","K012976","K192624","K011204","K013450","K003175","K172711","K961638","K031202","K860458","K201054","K983072","K854665","K033475","K131415","K142774","K173868","K974583","K050143","K242447","K021807","K241288","K983913","K071782","K172986","K971867","K101830",[83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130],"","3006418479","3018783526","3007389703","3008881376","3002459124","3008253300","3021736577","3000206198","3002806730","3009770872","3003501123","3030154814","3026753386","2518422","3013501110","3002807739","3023272766","3020018","3002807720","3015491430","3006125362","3007962724","3006258337","3011120183","1000139867","3016852448","1000271197","3003208775","3005733633","3004674371","3006177498","3001687738","3002797442","3007616088","2023374","3004964738","3012428212","3038189172","2080783","3027726372","3002716534","3007323246","1000160007","3002809369","3010611950","3005550372","3000126629",[83,84,132,133,85,134,86,87,135,136,89,90,92,93,137,95,138,96,97,98,100,101,103,104,105,106,107,109,139,112,114,115,116,117,118,140,119,120,141,121,122,123,125,128,129,130,142,143],"1650946","9710486","9615102","9617286","1529102","9611252","2184161","9612330","8030229","1063925","1530224","9613619","N","Y","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",1,"2018-08-08",64,0,21,[],[156,165,173,181,189,197,206,214,222,230],{"medical_device_id":157,"generic_name":158,"class_classification":159,"jmdn_code":160,"name_similarity":161,"definition_similarity":162,"vector_similarity":163,"score":164},1454,"脳波計","Ⅱ","11467010",0.478261,0.248677,0.790845,0.0327869,{"medical_device_id":166,"generic_name":167,"class_classification":159,"jmdn_code":168,"name_similarity":169,"definition_similarity":170,"vector_similarity":171,"score":172},1542,"テレメトリー式脳波計","35626000",0.4,0.269103,0.775873,0.032002,{"medical_device_id":174,"generic_name":175,"class_classification":159,"jmdn_code":176,"name_similarity":177,"definition_similarity":178,"vector_similarity":179,"score":180},1503,"脳波モニタ","35196000",0.368421,0.242915,0.773135,0.0305789,{"medical_device_id":182,"generic_name":183,"class_classification":159,"jmdn_code":184,"name_similarity":185,"definition_similarity":186,"vector_similarity":187,"score":188},3089,"脳波計用プログラム","11467032",0.396552,0.278196,0.729781,0.0299107,{"medical_device_id":190,"generic_name":191,"class_classification":159,"jmdn_code":192,"name_similarity":193,"definition_similarity":194,"vector_similarity":195,"score":196},1464,"脳波用増幅器","36740000",0.392857,0.2,0.722378,0.0288981,{"medical_device_id":198,"generic_name":199,"class_classification":200,"jmdn_code":201,"name_similarity":202,"definition_similarity":203,"vector_similarity":204,"score":205},3352,"頭皮脳波用電極","Ⅰ","11440001",0.44898,0.20438,0.704317,0.028629,{"medical_device_id":207,"generic_name":208,"class_classification":159,"jmdn_code":209,"name_similarity":210,"definition_similarity":211,"vector_similarity":212,"score":213},1538,"胎児脳波モニタ","32660000",0.333333,0.228571,0.732973,0.028624,{"medical_device_id":215,"generic_name":216,"class_classification":159,"jmdn_code":217,"name_similarity":218,"definition_similarity":219,"vector_similarity":220,"score":221},1462,"長時間脳波用データレコーダ","35163000",0.314286,0.213178,0.743815,0.0283094,{"medical_device_id":223,"generic_name":224,"class_classification":159,"jmdn_code":225,"name_similarity":226,"definition_similarity":227,"vector_similarity":228,"score":229},1519,"脳波モジュール","37323000",0.375,0.264881,0.721595,0.0282587,{"medical_device_id":231,"generic_name":232,"class_classification":159,"jmdn_code":233,"name_similarity":234,"definition_similarity":235,"vector_similarity":236,"score":237},3138,"テレメトリー式脳波計用プログラム","35626012",0.343284,0.287313,0.724413,0.0281914,[239,243,247,251,255,259,263,267,271,275,279,282],{"product_code":240,"device_name":241,"device_class":8,"k510_count":242},"GWQ","Full-Montage Standard Electroencephalograph",189,{"product_code":244,"device_name":245,"device_class":8,"k510_count":246},"OLT","Non-Normalizing Quantitative Electroencephalograph Software",55,{"product_code":248,"device_name":249,"device_class":8,"k510_count":250},"OMB","Automatic Event Detection Software For Full-Montage Electroencephalograph",42,{"product_code":252,"device_name":253,"device_class":8,"k510_count":254},"OLW","Index-Generating Electroencephalograph Software",39,{"product_code":256,"device_name":257,"device_class":8,"k510_count":258},"OLZ","Automatic Event Detection Software For Polysomnograph With Electroencephalograph",37,{"product_code":260,"device_name":261,"device_class":8,"k510_count":262},"OMC","Reduced- Montage Standard Electroencephalograph",29,{"product_code":264,"device_name":265,"device_class":8,"k510_count":266},"OLX","Source Localization Software For Electroencephalograph Or Magnetoencephalograph",24,{"product_code":268,"device_name":269,"device_class":8,"k510_count":270},"OMA","Amplitude-Integrated Electroencephalograph",16,{"product_code":272,"device_name":273,"device_class":8,"k510_count":274},"OLU","Normalizing Quantitative Electroencephalograph Software",13,{"product_code":276,"device_name":277,"device_class":8,"k510_count":278},"OLY","Magnetoencephalograph",6,{"product_code":280,"device_name":281,"device_class":8,"k510_count":149},"ORT","Burst Suppression Detection Software For Electroencephalograph",{"product_code":283,"device_name":284,"device_class":8,"k510_count":149},"SFK","Respiratory Effort Belt For Polysomnography",{"510k":286,"classification":287,"enforcement":288,"event":289,"pma":290,"warning_letter":291},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]