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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 K220907
Device Name The iNAP One Sleep Therapy System
Applicant
Somnics, Inc.
5f, N0. 22, 5f, # 22, Sec. 2, Shengyi Rd., Zhubei City,
Hsinchu County,  TW 30261
Applicant Contact Chung-Chu Chen
Correspondent
Ivdd Regulatory Consultant
29122 Rancho Viejo Rd., Suite 212
San Juan,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number872.5570
Classification Product Code
OZR  
Date Received03/29/2022
Decision Date 06/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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