Cleared Traditional

Withings Sleep Rx

K231667 · Withings · Anesthesiology
Sep 2024
Decision
457d
Days
Class 2
Risk

About This 510(k) Submission

K231667 is an FDA 510(k) clearance for the Withings Sleep Rx, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Withings (Issy-Les-Moulineaux, FR). The FDA issued a Cleared decision on September 6, 2024, 457 days after receiving the submission on June 7, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K231667 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2023
Decision Date September 06, 2024
Days to Decision 457 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375