FDA 510(k)

SleepRes PAP System

Número K: K251770 · 2025-12-15

Data da decisão2025-12-15

Código do produtoBZD

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

SleepRes PAP System is the device name listed in this FDA 510(k) record. The listed applicant is Sleepres, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K251770. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SleepRes PAP System?

SleepRes PAP System is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Sleepres, Inc.. The 510(k) number is K251770.

When did SleepRes PAP System receive FDA 510(k) clearance?

SleepRes PAP System received FDA 510(k) clearance on 2025-12-15, under 510(k) number K251770.

Who is the listed applicant for SleepRes PAP System?

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

What is the FDA product code for SleepRes PAP System?

The FDA product code for SleepRes PAP System is BZD.

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Fonte oficial

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