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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 K183625
Device Name SomnaPatch
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Applicant Contact Amy Panzik
Respironics, Inc.
1740 Golden Mile Highway
Monroeville,  PA  15146
Correspondent Contact Amy Panzik
Regulation Number868.2375
Classification Product Code
Date Received12/26/2018
Decision Date 10/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT02034175
Reviewed by Third Party No
Combination Product No