FDA 510(k) Application Details - K200698

Device Classification Name	More FDA Info for this Device
510(K) Number	K200698
Device Name	Somnera System
Applicant	FRESCA Medical Inc. 1291 Puerta Del Sol Suite #200 San Clemente, CA 92673 US Other 510(k) Applications for this Company
Contact	Mary Lou Mooney Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2020
Decision Date	06/29/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review