Data da decisão2022-01-27
Código do produtoDSA
Comité consultivoCV
DecisãoSubstantially Equivalent
Resumo do dispositivo
9Line is the device name listed in this FDA 510(k) record. The listed applicant is Energetic Designs, Inc.. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K211941. 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 9Line?
9Line is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Energetic Designs, Inc.. The 510(k) number is K211941.
When did 9Line receive FDA 510(k) clearance?
9Line received FDA 510(k) clearance on 2022-01-27, under 510(k) number K211941.
Who is the listed applicant for 9Line?
The FDA 510(k) record lists Energetic Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 9Line?
The FDA product code for 9Line is DSA.
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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.