FDA 510(k) Application Details - DEN170089

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170089
Device Name	Curve Positive Airway Pressure System
Applicant	FRESCA Medical 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	12/14/2017
Decision Date	06/05/2018
Decision	DENG -
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review