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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 a medical device manufactured by Withings. It received FDA 510(k) clearance on 2024-09-06 under approval 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. It is manufactured by Withings. The 510(k) number is K231667.

When was Withings Sleep Rx approved by the FDA?

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

What company makes Withings Sleep Rx?

Withings Sleep Rx is manufactured by Withings.

What is the FDA product code for Withings Sleep Rx?

The FDA product code for Withings Sleep Rx is MNR.

Related Clinical Trials

Other Devices by Withings

Related Devices (Code: MNR)

Official Source

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