FDA 510(k) Application Details - K172859

Device Classification Name	More FDA Info for this Device
510(K) Number	K172859
Device Name	Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
Applicant	Prosomnous Sleep Technologies 5860 W. Las Positas Blvd., Suite 25 Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	David Kuhns Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2017
Decision Date	11/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review