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FDA 510(k)

Sunset Heated CPAP Tube

Número K: K201418 · 2021-01-29

RequerenteSunset Healthcare Solutions, Inc.
Data da decisão2021-01-29
Código do produtoBZE
Comité consultivoAN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sunset Heated CPAP Tube is the device name listed in this FDA 510(k) record. The listed applicant is Sunset Healthcare Solutions, Inc.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K201418. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sunset Heated CPAP Tube?

Sunset Heated CPAP Tube is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Sunset Healthcare Solutions, Inc.. The 510(k) number is K201418.

When did Sunset Heated CPAP Tube receive FDA 510(k) clearance?

Sunset Heated CPAP Tube received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201418.

Who is the listed applicant for Sunset Heated CPAP Tube?

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

What is the FDA product code for Sunset Heated CPAP Tube?

The FDA product code for Sunset Heated CPAP Tube is BZE.

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Dispositivos Relacionados (Código: BZE)

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