FDA 510(k) Application Details - K082558

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K082558
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY MONROEVILLE, PA 15146 US Other 510(k) Applications for this Company
Contact	ANDREW ZELTWANGER 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	09/04/2008
Decision Date	03/25/2009
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