FDA 510(k) Application Details - K220907

Device Classification Name	More FDA Info for this Device
510(K) Number	K220907
Device Name	The iNAP One Sleep Therapy System
Applicant	Somnics Inc. 5F, N0. 22, 5F, No. 22, Sec. 2, Shengyi Rd., Zhubei City, Hsinchu County 30261 TW Other 510(k) Applications for this Company
Contact	Chung-Chu Chen 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	03/29/2022
Decision Date	06/16/2023
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