Data da decisão2018-02-28
Código do produtoDSA
Comité consultivoCV
DecisãoSubstantially Equivalent
Resumo do dispositivo
ECG Cable/Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K172797. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Perguntas frequentes
What is the ECG Cable/Leadwires?
ECG Cable/Leadwires is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Shenzhen Coreray Technology, Ltd.. The 510(k) number is K172797.
When did ECG Cable/Leadwires receive FDA 510(k) clearance?
ECG Cable/Leadwires received FDA 510(k) clearance on 2018-02-28, under 510(k) number K172797.
Who is the listed applicant for ECG Cable/Leadwires?
The FDA 510(k) record lists Shenzhen Coreray Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ECG Cable/Leadwires?
The FDA product code for ECG Cable/Leadwires is DSA.
Ensaios clínicos relacionados
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.
Outros registros que listam Shenzhen Coreray Technology, 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.
Dispositivos Relacionados (Código: DSA)
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.
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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.