FDA 510(k)

Strados Remote Electronic Stethoscope Platform (RESP)

Número K: K201077 · 2020-12-20

Data da decisão2020-12-20

Código do produtoDSH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Strados Remote Electronic Stethoscope Platform (RESP) is the device name listed in this FDA 510(k) record. The listed applicant is Strados Labs. It received FDA 510(k) clearance on 2020-12-20 under 510(k) number K201077. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Strados Remote Electronic Stethoscope Platform (RESP)?

Strados Remote Electronic Stethoscope Platform (RESP) is a medical device that received FDA 510(k) clearance on 2020-12-20. The listed applicant is Strados Labs. The 510(k) number is K201077.

When did Strados Remote Electronic Stethoscope Platform (RESP) receive FDA 510(k) clearance?

Strados Remote Electronic Stethoscope Platform (RESP) received FDA 510(k) clearance on 2020-12-20, under 510(k) number K201077.

Who is the listed applicant for Strados Remote Electronic Stethoscope Platform (RESP)?

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

What is the FDA product code for Strados Remote Electronic Stethoscope Platform (RESP)?

The FDA product code for Strados Remote Electronic Stethoscope Platform (RESP) is DSH.

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