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FDA 510(k)

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

Número K: K190353 · 2020-04-10

RequerenteResidential Home Sleep Services
Data da decisão2020-04-10
Código do produtoPLC
Comité consultivoDE
DecisãoSubstantially Equivalent

Resumo do dispositivo

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac is the device name listed in this FDA 510(k) record. The listed applicant is Residential Home Sleep Services. It received FDA 510(k) clearance on 2020-04-10 under 510(k) number K190353. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac?

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac is a medical device that received FDA 510(k) clearance on 2020-04-10. The listed applicant is Residential Home Sleep Services. The 510(k) number is K190353.

When did Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac receive FDA 510(k) clearance?

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac received FDA 510(k) clearance on 2020-04-10, under 510(k) number K190353.

Who is the listed applicant for Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac?

The FDA 510(k) record lists Residential Home Sleep Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac?

The FDA product code for Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac is PLC.

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