FDA 510(k)

HeartBuds Electronic Stethoscope

Número K: K212906 · 2023-03-14

Data da decisão2023-03-14

Código do produtoDQD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

HeartBuds Electronic Stethoscope is the device name listed in this FDA 510(k) record. The listed applicant is Heartbuds, LLC. It received FDA 510(k) clearance on 2023-03-14 under 510(k) number K212906. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HeartBuds Electronic Stethoscope?

HeartBuds Electronic Stethoscope is a medical device that received FDA 510(k) clearance on 2023-03-14. The listed applicant is Heartbuds, LLC. The 510(k) number is K212906.

When did HeartBuds Electronic Stethoscope receive FDA 510(k) clearance?

HeartBuds Electronic Stethoscope received FDA 510(k) clearance on 2023-03-14, under 510(k) number K212906.

Who is the listed applicant for HeartBuds Electronic Stethoscope?

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

What is the FDA product code for HeartBuds Electronic Stethoscope?

The FDA product code for HeartBuds Electronic Stethoscope is DQD.

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