Withings Sleep Rx
by Withings
510(k) K231667
Withings Sleep Rx is a Class II device made by Withings, cleared under FDA 510(k) K231667 on 6 Sep 2024, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231667 | Date6 Sep 2024 | StatusActive |
Official records
- FDA 510(k) database K231667
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNR
- Device class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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