Data da decisão2024-05-07
Código do produtoDSA
Comité consultivoCV
DecisãoSubstantially Equivalent
Resumo do dispositivo
LIFEPAK® ECG Cables is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Physio-Control. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K240377. 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 LIFEPAK® ECG Cables?
LIFEPAK® ECG Cables is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Stryker Physio-Control. The 510(k) number is K240377.
When did LIFEPAK® ECG Cables receive FDA 510(k) clearance?
LIFEPAK® ECG Cables received FDA 510(k) clearance on 2024-05-07, under 510(k) number K240377.
Who is the listed applicant for LIFEPAK® ECG Cables?
The FDA 510(k) record lists Stryker Physio-Control as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LIFEPAK® ECG Cables?
The FDA product code for LIFEPAK® ECG Cables 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 Stryker Physio-Control 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.