Withings Sleep Rx— 510(k) K231667

Substantially Equivalent

Withings

FDA 510(k) clearance K231667 for Withings Sleep Rx, Substantially Equivalent on 2024-09-06. Applicant: Withings. Device class: 2.

Clearance details

Applicant: Withings
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2023-06-07
Decision date: 2024-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issy-Les-Moulineaux, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNR

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Data sourced from openFDA. This site is unofficial and independent of the FDA.