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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K231667
Device Name Withings Sleep Rx
Applicant
Withings
2 Rue Maurice Hartmann
Issy-Les-Moulineaux,  FR 92130
Applicant Contact Khushboo Surendran
Correspondent
Withings
2 Rue Maurice Hartmann
Issy-Les-Moulineaux,  FR 92130
Correspondent Contact Khushboo Surendran
Regulation Number868.2375
Classification Product Code
MNR  
Date Received06/07/2023
Decision Date 09/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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