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FDA 510(k)

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

K-Number: K190353 · 2020-04-10

ApplicantResidential Home Sleep Services
Decision Date2020-04-10
Product CodePLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Residential Home Sleep Services. The 510(k) number is K190353.

When was Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac approved by the FDA?

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

What company makes 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 manufactured by Residential Home Sleep Services.

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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Related Devices (Code: PLC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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