[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QVT":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":109,"syncDates":110,"translation":117,"marketSummary":124,"recalls":137,"k510s":139,"pmas":146},{"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":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":24},6521,"QVT","Monitor For Opioid Induced Impairment Of Oxygenation","2","868.2250","AN","Anesthesiology","1","A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and  software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose",false,{"openfda":16,"definition":13,"device_name":7,"review_code":19,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":10,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":19,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":21},{"k_number":17},[18],"DEN200011","","N","Ineligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:48.620842+00:00",0,null,1,[],[29,38,47,55,63,71,78,86,94,102],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":35,"vector_similarity":36,"score":37},1501,"呼吸モニタ","Ⅱ","35194002",0.210526,0.210317,0.74897,0.03125,{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":44,"vector_similarity":45,"score":46},114,"酸素飽和度モニタ付サーモダイリューション用カテーテル","Ⅳ","36218100",0.214286,0.208696,0.738942,0.0307984,{"medical_device_id":48,"generic_name":49,"class_classification":32,"jmdn_code":50,"name_similarity":51,"definition_similarity":52,"vector_similarity":53,"score":54},1495,"換気モニタ","12678000",0.232143,0.181818,0.706012,0.0277569,{"medical_device_id":56,"generic_name":57,"class_classification":41,"jmdn_code":58,"name_similarity":59,"definition_similarity":60,"vector_similarity":61,"score":62},115,"ヘパリン使用酸素飽和度モニタ付サーモダイリューション用カテーテル","36218200",0.195876,0.204167,0.701574,0.0260365,{"medical_device_id":64,"generic_name":65,"class_classification":32,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":70},1520,"心臓内オキシメータ","15200000",0.0597015,0.280335,0.761949,0.0163934,{"medical_device_id":72,"generic_name":73,"class_classification":32,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":70},3131,"呼吸モニタ用プログラム","35194012",0.227273,0.232068,0.676511,{"medical_device_id":79,"generic_name":80,"class_classification":81,"jmdn_code":82,"name_similarity":83,"definition_similarity":34,"vector_similarity":84,"score":85},342,"無呼吸モニタ","Ⅲ","35194003",0.142857,0.761097,0.016129,{"medical_device_id":87,"generic_name":88,"class_classification":32,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":93},2446,"酸素コントローラ","70577000",0.0983607,0.213115,0.755368,0.015873,{"medical_device_id":95,"generic_name":96,"class_classification":41,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":101},110,"オキシメトリー用バルーン付カテーテル","35856100",0.038961,0.234513,0.743968,0.0153846,{"medical_device_id":103,"generic_name":104,"class_classification":32,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":101},3056,"神経モニタ用プログラム","36081012",0.202899,0.239837,0.692656,[],{"510k":111,"classification":112,"enforcement":113,"event":114,"pma":115,"warning_letter":116},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":118,"definition_ja":119,"commentary_ja":120,"model_name":121,"source_hash":122,"reviewed_by":25,"reviewed_at":25,"created_at":123,"updated_at":123},"オピオイド誘発性酸素化障害モニタ","オピオイド誘発性酸素化障害モニタとは、センサーハードウェア及びソフトウェアアルゴリズムを用いて、オピオイド過剰投与に起因する動脈血酸素飽和度の低下を検出する機器である。","本品は米国においてクラスIIに分類されており、市販前届出（510(k)）による審査を経て市販が認められる医療機器です。510(k)では、既存の同等な機器（プレディケイトデバイス）との実質的同等性を示すことにより安全性・有効性が確認される仕組みとなっています。","claude-sonnet-5","53f6e1597d5d76663ebd714ff063107f7d9a0eaa4f10399369fbbabe65ce703c","2026-08-24T03:33:38.802601+00:00",{"product_code":6,"summary_ja":125,"stats":126,"stats_hash":135,"model_name":121,"created_at":136,"updated_at":136},"本製品コードでは、510(k)の累計件数は1件、参入企業数は1社となっており、直近5年間でも1件の届出が確認されています。PMAによる承認実績は本承認・一部変更承認ともに確認されていません。不具合報告および回収については、いずれも累計件数が0件となっており、報告・実績は確認されていません。",{"pma":127,"k510":128,"as_of":130,"events":131,"recalls":132,"top_problems":134},{"latest":25,"originals":24,"supplements":24},{"total":26,"last5y":26,"latest":129,"applicants":26},"2023-03-31","2026-08",{"death":24,"other":24,"total":24,"injury":24,"last5y":24,"malfunction":24,"latest_month":25},{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":133},[],[],"6610a969edd4e9baedad3890138248bd102509f6584de3f5a4e62b6afdff569c","2026-08-24T05:21:03.140427+00:00",{"items":138,"total":24},[],{"items":140,"total":26},[141],{"k_number":18,"device_name":142,"applicant":143,"decision_date":129,"clearance_type":144,"decision_code":145,"statement_or_summary":25},"Masimo SafetyNet","Masimo Corporation","Direct","DENG",{"items":147,"total":24},[]]