[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NVO":3},{"classification":4,"mappedDevices":35,"similarCandidates":36,"relatedClassifications":119,"syncDates":131},{"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":30,"updated_at":31,"recall_count":32,"latest_recall_date":33,"k510_count":34,"pma_count":32,"event_count":32},4447,"NVO","Spacer, Direct Patient Interface","2","868.5630","AN","Anesthesiology","1","Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed.  A spacer uses an open mouthpiece.  Spacers are intended to minimize delivery of large aerosolized particles.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":27,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":27,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":29},{"k_number":17,"fei_number":20,"registration_number":24},[18,19],"K091862","K101532",[21,22,23],"1000374126","3006500694","3003319165",[25,22,26],"2028807","8043316","","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,[],[37,46,54,63,71,79,86,94,103,111],{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":43,"vector_similarity":44,"score":45},621,"骨スペーサ","Ⅲ","33982003",0.25,0.185053,0.76072,0.0325225,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":42,"definition_similarity":51,"vector_similarity":52,"score":53},4119,"歯科用スペーサ","Ⅰ","44575000",0.189655,0.745348,0.0320184,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":59,"definition_similarity":60,"vector_similarity":61,"score":62},249,"吸収性骨スペーサ","Ⅳ","33982004",0.191489,0.152344,0.740842,0.0305361,{"medical_device_id":64,"generic_name":65,"class_classification":40,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":70},627,"腱鞘スペーサ","35671003",0.184211,0.141762,0.748175,0.0301587,{"medical_device_id":72,"generic_name":73,"class_classification":57,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},1141,"植込み医療機器用吸収性スペーサ","71062004",0.169492,0.204861,0.756449,0.0296425,{"medical_device_id":80,"generic_name":81,"class_classification":40,"jmdn_code":82,"name_similarity":75,"definition_similarity":83,"vector_similarity":84,"score":85},613,"関節全置換術用セメントスペーサ","44267000",0.167286,0.711658,0.0274436,{"medical_device_id":87,"generic_name":88,"class_classification":57,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":93},157,"ブラキセラピー線源用スペーサ","70411000",0.152542,0.201754,0.711519,0.0267427,{"medical_device_id":95,"generic_name":96,"class_classification":97,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},2508,"間欠型空気圧式マッサージ器","Ⅱ","10969000",0.15625,0.178462,0.676634,0.0250156,{"medical_device_id":104,"generic_name":105,"class_classification":49,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":110},4279,"直達肛門括約筋鏡","15787001",0.227273,0.130233,0.577152,0.015873,{"medical_device_id":112,"generic_name":113,"class_classification":49,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":118},3308,"放射線防護用患者向け眼鏡","38361000",0.203704,0.201183,0.569578,0.015625,[120,124,128],{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"CAF","Nebulizer (Direct Patient Interface)",508,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"NVP","Holding Chambers, Direct Patient Interface",16,{"product_code":129,"device_name":130,"device_class":8,"k510_count":34},"SFP","Ventilator-Compatible Nebulizer",{"510k":132,"classification":133,"enforcement":134,"event":135,"pma":136,"warning_letter":137},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]