FDA 510(k) Application Details - K132003

Device Classification Name	More FDA Info for this Device
510(K) Number	K132003
Device Name	WINX SLEEP THERAPY SYSTEM
Applicant	APNICURE, INC. 900 CHESAPEAKE DR REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	CHRIS DANIEL 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	07/01/2013
Decision Date	06/13/2014
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