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FDA 510(k)

SleepRes PAP System

K-Number: K251770 · 2025-12-15

ApplicantSleepres, Inc.
Decision Date2025-12-15
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the SleepRes PAP System?

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

When was SleepRes PAP System approved by the FDA?

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

What company makes SleepRes PAP System?

SleepRes PAP System is manufactured by Sleepres, Inc..

What is the FDA product code for SleepRes PAP System?

The FDA product code for SleepRes PAP System is BZD.

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Official Source

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