FDA 510(k) Application Details - K193460

Device Classification Name	More FDA Info for this Device
510(K) Number	K193460
Device Name	The iNAP One Sleep Therapy System
Applicant	Somnice, Inc. 5F, No. 22, Sec. 2, Shengyi Rd., Hsinchu Science Park, Zhubei City Hsinchu County 30261 TW Other 510(k) Applications for this Company
Contact	Sujith Shetty Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2019
Decision Date	05/26/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review