FDA 510(k) Application Details - K132168

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K132168
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT PITTSBURGH, PA 15239 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	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2013
Decision Date	11/20/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review