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FDA 510(k)

Withings Sleep Rx

K-Number: K231667 · 2024-09-06

ApplicantWithings
Decision Date2024-09-06
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Withings Sleep Rx is the device name listed in this FDA 510(k) record. The listed applicant is Withings. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K231667. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Withings Sleep Rx?

Withings Sleep Rx is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Withings. The 510(k) number is K231667.

When did Withings Sleep Rx receive FDA 510(k) clearance?

Withings Sleep Rx received FDA 510(k) clearance on 2024-09-06, under 510(k) number K231667.

Who is the listed applicant for Withings Sleep Rx?

The FDA 510(k) record lists Withings as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Withings Sleep Rx?

The FDA product code for Withings Sleep Rx is MNR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06637878SCT02 Clinical Accuracy ValidationCOMPLETEDNCT07595016Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-EclampsiaRECRUITINGNCT07631715Withings Hypertension Notification Retrospective StudyACTIVE_NOT_RECRUITINGNCT07654491Withings HFRN Retrospective StudyNOT_YET_RECRUITING

Other records listing Withings as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252474Withings BeamO (SCT02)K240795Withings ECG AppK230812Withings Scan Monitor 2.0K201456Scan MonitorK160544Withings Thermo (Model SCT01)

Related Devices (Code: MNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley MedicalK250882SANSA HSATHuxley Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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