FDA 510(k)

Estetoscópio Eletrônico AccurSound AS-101

Número K: K221805 · 2023-03-23

RequerenteHeroic Faith International , Ltd.

Data da decisão2023-03-23

Código do produtoDQD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AccurSound Electronic Stethoscope AS-101 is the device name listed in this FDA 510(k) record. The listed applicant is Heroic Faith International , Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K221805. 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 AccurSound Electronic Stethoscope AS-101?

AccurSound Electronic Stethoscope AS-101 is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Heroic Faith International , Ltd.. The 510(k) number is K221805.

When did AccurSound Electronic Stethoscope AS-101 receive FDA 510(k) clearance?

AccurSound Electronic Stethoscope AS-101 received FDA 510(k) clearance on 2023-03-23, under 510(k) number K221805.

Who is the listed applicant for AccurSound Electronic Stethoscope AS-101?

The FDA 510(k) record lists Heroic Faith International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccurSound Electronic Stethoscope AS-101?

The FDA product code for AccurSound Electronic Stethoscope AS-101 is DQD.

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Outros registros que listam Heroic Faith International , Ltd. como candidato(a)

K242798Airmod K242971Estetoscópio Eletrônico AccurSound (AS101)

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