[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GIE":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":105,"syncDates":121},{"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":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":28,"event_count":31},932,"GIE","Fibrometer","2","864.5400","HE","Hematology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":10,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"k_number":17,"fei_number":20,"registration_number":23},[18,19],"K820533","K820532",[21,22],"3024820199","3013660430",[21,22],"N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,5,[],[34,42,49,56,63,70,77,84,92,98],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":28,"vector_similarity":40,"score":41},1565,"ピークフロースパイロメータ","Ⅱ","31300000",0.28,0.66049,0.0295139,{"medical_device_id":43,"generic_name":44,"class_classification":37,"jmdn_code":45,"name_similarity":46,"definition_similarity":28,"vector_similarity":47,"score":48},1563,"黄疸計","70078000",0.375,0.64465,0.029116,{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":46,"definition_similarity":28,"vector_similarity":54,"score":55},3408,"眼位計","Ⅰ","17119000",0.627732,0.0280214,{"medical_device_id":57,"generic_name":58,"class_classification":52,"jmdn_code":59,"name_similarity":60,"definition_similarity":28,"vector_similarity":61,"score":62},3411,"ジストメータ","32741000",0.294118,0.64832,0.0280063,{"medical_device_id":64,"generic_name":65,"class_classification":37,"jmdn_code":66,"name_similarity":67,"definition_similarity":28,"vector_similarity":68,"score":69},2912,"角膜知覚計","70974000",0.238095,0.679119,0.0278937,{"medical_device_id":71,"generic_name":72,"class_classification":52,"jmdn_code":73,"name_similarity":74,"definition_similarity":28,"vector_similarity":75,"score":76},4401,"眼球突出計","16345000",0.217391,0.673399,0.0272367,{"medical_device_id":78,"generic_name":79,"class_classification":52,"jmdn_code":80,"name_similarity":81,"definition_similarity":28,"vector_similarity":82,"score":83},3374,"回転式肺活量計","70083000",0.26087,0.654167,0.0270516,{"medical_device_id":85,"generic_name":86,"class_classification":87,"jmdn_code":88,"name_similarity":89,"definition_similarity":28,"vector_similarity":90,"score":91},103,"光ファイバオキシメトリー用カテーテル","Ⅳ","31659100",0.25,0.651452,0.0263339,{"medical_device_id":93,"generic_name":94,"class_classification":37,"jmdn_code":95,"name_similarity":60,"definition_similarity":28,"vector_similarity":96,"score":97},1427,"膀胱計","11111000",0.622579,0.0262626,{"medical_device_id":99,"generic_name":100,"class_classification":52,"jmdn_code":101,"name_similarity":102,"definition_similarity":28,"vector_similarity":103,"score":104},3404,"眼筋計","12822000",0.263158,0.625941,0.0244813,[106,110,114,118],{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"GKP","Instrument, Coagulation, Automated",49,{"product_code":111,"device_name":112,"device_class":8,"k510_count":113},"KQG","Instrument, Coagulation",14,{"product_code":115,"device_name":116,"device_class":8,"k510_count":117},"GKN","Timer, Clot, Automated",3,{"product_code":119,"device_name":120,"device_class":8,"k510_count":28},"JBT","Timer, Coagulation",{"510k":122,"classification":123,"enforcement":124,"event":125,"pma":126,"warning_letter":127},"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"]