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510(k) K231667

Withings Sleep Rx by Withings — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2024
Date Received
June 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Withings

  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K240795 — Withings ECG App (June 15, 2025)
  • K230812 — Withings Scan Monitor 2.0 (August 23, 2023)
  • K201456 — Scan Monitor (October 5, 2021)
  • K160544 — Withings Thermo (Model SCT01) (June 17, 2016)
  • K133125 — WITHINGS BLOOD PRESURE MONITOR (March 24, 2014)
  • K110872 — WITHINGS BLOOD PRESSURE MONITOR (May 20, 2011)

Other clearances for product code MNR

  • K252497 — SANSA HSAT (December 10, 2025)
  • K250882 — SANSA HSAT (October 29, 2025)
  • K250460 — WatchPAT400 (WP400) (September 5, 2025)
  • K252383 — Somfit D (August 28, 2025)
  • K243220 — Onera STS 2 (ONERA STS 2) (July 3, 2025)
  • K242224 — Happy Health Home Sleep Test (June 18, 2025)
  • K243092 — AcuPebble Ox (200) (March 19, 2025)
  • K243268 — TipTraQ (TTQ001) (February 3, 2025)
  • K244027 — SANSA HSAT (January 28, 2025)
  • K242290 — DormoTech NLab (January 8, 2025)