FDA 510(k)

AISAP Cardio V1.0

Número K: K234141 · 2024-08-01

RequerenteAisap

Data da decisão2024-08-01

Código do produtoPOK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

AISAP Cardio V1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Aisap. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K234141. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AISAP Cardio V1.0?

AISAP Cardio V1.0 is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Aisap. The 510(k) number is K234141.

When did AISAP Cardio V1.0 receive FDA 510(k) clearance?

AISAP Cardio V1.0 received FDA 510(k) clearance on 2024-08-01, under 510(k) number K234141.

Who is the listed applicant for AISAP Cardio V1.0?

The FDA 510(k) record lists Aisap as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AISAP Cardio V1.0?

The FDA product code for AISAP Cardio V1.0 is POK.

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Fonte oficial

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