[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MCE":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":112,"syncDates":127},{"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":33,"updated_at":34,"recall_count":35,"latest_recall_date":36,"k510_count":37,"pma_count":35,"event_count":35},2377,"MCE","Respiratory Syncytial Virus - Elisa","1","866.3480","MI","Microbiology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":10,"gmp_exempt_flag":31,"third_party_flag":31,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":31,"medical_specialty_description":11,"summary_malfunction_reporting":32},{"k_number":17,"fei_number":20,"registration_number":29},[18,19],"K061008","K924289",[21,22,23,24,25,26,27,28],"3003268355","3007361513","3000717645","3007118747","3002800697","3005542422","2245285","3029917416",[21,22,24,30,25,26,27,28],"2133982","N","Eligible","2026-08-18T05:52:49.993647+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,[],[40,48,56,64,71,78,85,92,99,105],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":35,"vector_similarity":46,"score":47},1566,"呼吸流量計","Ⅱ","70079010",0.266667,0.589325,0.0317781,{"medical_device_id":49,"generic_name":50,"class_classification":51,"jmdn_code":52,"name_similarity":53,"definition_similarity":35,"vector_similarity":54,"score":55},3366,"呼吸センサ","Ⅰ","70072000",0.204545,0.599083,0.0306792,{"medical_device_id":57,"generic_name":58,"class_classification":59,"jmdn_code":60,"name_similarity":61,"definition_similarity":35,"vector_similarity":62,"score":63},345,"心電・呼吸モジュール","Ⅲ","36548000",0.233333,0.578882,0.0296443,{"medical_device_id":65,"generic_name":66,"class_classification":43,"jmdn_code":67,"name_similarity":68,"definition_similarity":35,"vector_similarity":69,"score":70},1567,"呼吸抵抗計","70079020",0.25,0.561179,0.0282187,{"medical_device_id":72,"generic_name":73,"class_classification":43,"jmdn_code":74,"name_similarity":75,"definition_similarity":35,"vector_similarity":76,"score":77},1579,"呼吸機能測定装置","35282020",0.241379,0.56004,0.0278201,{"medical_device_id":79,"generic_name":80,"class_classification":43,"jmdn_code":81,"name_similarity":82,"definition_similarity":35,"vector_similarity":83,"score":84},1501,"呼吸モニタ","35194002",0.2,0.564489,0.0267094,{"medical_device_id":86,"generic_name":87,"class_classification":51,"jmdn_code":88,"name_similarity":89,"definition_similarity":35,"vector_similarity":90,"score":91},3367,"胸腹呼吸センサ","70073000",0.153846,0.576684,0.0259136,{"medical_device_id":93,"generic_name":94,"class_classification":43,"jmdn_code":95,"name_similarity":96,"definition_similarity":35,"vector_similarity":97,"score":98},1495,"換気モニタ","12678000",0.0384615,0.59398,0.016129,{"medical_device_id":100,"generic_name":101,"class_classification":43,"jmdn_code":102,"name_similarity":103,"definition_similarity":35,"vector_similarity":104,"score":98},2524,"能動型呼吸運動訓練装置","11634002",0.26,0.528745,{"medical_device_id":106,"generic_name":107,"class_classification":43,"jmdn_code":108,"name_similarity":109,"definition_similarity":35,"vector_similarity":110,"score":111},1557,"呼吸曲線図データレコーダ","35244000",0.0333333,0.59234,0.015873,[113,117,121,124],{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"GQG","Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus",32,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"LKT","Respiratory Syncytial Virus, Antigen, Antibody, Ifa",23,{"product_code":122,"device_name":123,"device_class":8,"k510_count":35},"GQF","Antiserum, Neutralization, Respiratory Syncytial Virus",{"product_code":125,"device_name":126,"device_class":8,"k510_count":35},"NHY","Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus",{"510k":128,"classification":129,"enforcement":130,"event":131,"pma":132,"warning_letter":133},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]