FDA 510(k)

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85

Número K: K180543 · 2018-05-24

Data da decisão2018-05-24

Código do produtoKPR

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K180543. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K180543.

When did GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 receive FDA 510(k) clearance?

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 received FDA 510(k) clearance on 2018-05-24, under 510(k) number K180543.

Who is the listed applicant for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

The FDA product code for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 is KPR.

Outros registros que listam Samsung Electronics Co., Ltd. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K260481GC85A K261187Hearing Aid Feature K261011Característica de Apneia do Sono (v2.0)K242651GM85 K242478GF85 (models GF85-3P, GF85-SP)K240909Samsung ECG App v 1.3 (ECG)

Ver todos os 26 dispositivos →

Dispositivos Relacionados (Código: KPR)

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH Corporation K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.