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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intraoral Pressure Gradient Device
510(k) Number K193460
Device Name The iNAP One Sleep Therapy System
Applicant
Somnice, Inc.
5f, # 22, Sec. 2, Shengyi Rd., Hsinchu Science Park,
Zhubei City
Hsinchu County,  TW 30261
Applicant Contact Sujith Shetty
Correspondent
Maxis, LLC
75 E. Santa Clara St. 6th Floor
San Jose,  CA  95113
Correspondent Contact Sujith Shetty
Regulation Number872.5570
Classification Product Code
OZR  
Date Received12/16/2019
Decision Date 05/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT02324790
NCT02698059
NCT03544463
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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