FDA 510(k)

Medaica M1 Telehealth Stethoscope

Número K: K223166 · 2023-01-19

Data da decisão2023-01-19

Código do produtoDQD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medaica M1 Telehealth Stethoscope is the device name listed in this FDA 510(k) record. The listed applicant is Medaica, Inc.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K223166. 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 Medaica M1 Telehealth Stethoscope?

Medaica M1 Telehealth Stethoscope is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Medaica, Inc.. The 510(k) number is K223166.

When did Medaica M1 Telehealth Stethoscope receive FDA 510(k) clearance?

Medaica M1 Telehealth Stethoscope received FDA 510(k) clearance on 2023-01-19, under 510(k) number K223166.

Who is the listed applicant for Medaica M1 Telehealth Stethoscope?

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

What is the FDA product code for Medaica M1 Telehealth Stethoscope?

The FDA product code for Medaica M1 Telehealth Stethoscope is DQD.

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