FDA 510(k)

Sistema Somnera

Número K: K200698 · 2020-06-29

Data da decisão2020-06-29

Código do produtoQBY

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Somnera System is the device name listed in this FDA 510(k) record. The listed applicant is Fresca Medical, Inc.. It received FDA 510(k) clearance on 2020-06-29 under 510(k) number K200698. The device is classified under product code QBY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Somnera System?

Somnera System is a medical device that received FDA 510(k) clearance on 2020-06-29. The listed applicant is Fresca Medical, Inc.. The 510(k) number is K200698.

When did Somnera System receive FDA 510(k) clearance?

Somnera System received FDA 510(k) clearance on 2020-06-29, under 510(k) number K200698.

Who is the listed applicant for Somnera System?

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

What is the FDA product code for Somnera System?

The FDA product code for Somnera System is QBY.

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