FDA 510(k) Application Details - K111549

Device Classification Name	More FDA Info for this Device
510(K) Number	K111549
Device Name	ATTUNE SLEEP APNEA 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	06/03/2011
Decision Date	03/30/2012
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