FDA 510(k) Application Details - K121955

Device Classification Name	Device, Positive Pressure Breathing, Intermittent   More FDA Info for this Device
510(K) Number	K121955
Device Name	Device, Positive Pressure Breathing, Intermittent
Applicant	RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY MONROEVILLE, PA 15146 US Other 510(k) Applications for this Company
Contact	COLLEEN WITT Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	NHJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2012
Decision Date	12/14/2012
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