FDA 510(k)

Sistema de Avaliação de Risco de Apnéia (ARES), Modelo 620

Número K: K160499 · 2017-04-24

Data da decisão2017-04-24

Código do produtoMNR

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Apnea Risk Evaluation System (ARES), Model 620 is the device name listed in this FDA 510(k) record. The listed applicant is Watermark Medical. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K160499. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Apnea Risk Evaluation System (ARES), Model 620?

Apnea Risk Evaluation System (ARES), Model 620 is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Watermark Medical. The 510(k) number is K160499.

When did Apnea Risk Evaluation System (ARES), Model 620 receive FDA 510(k) clearance?

Apnea Risk Evaluation System (ARES), Model 620 received FDA 510(k) clearance on 2017-04-24, under 510(k) number K160499.

Who is the listed applicant for Apnea Risk Evaluation System (ARES), Model 620?

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

What is the FDA product code for Apnea Risk Evaluation System (ARES), Model 620?

The FDA product code for Apnea Risk Evaluation System (ARES), Model 620 is MNR.

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