FDA 510(k) Application Details - K034040

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K034040
Device Name	Ventilator, Continuous, Facility Use
Applicant	RESPIRONICS, INC. 2271 COSMOS COURT CARLSBAD, CA 92009-1517 US Other 510(k) Applications for this Company
Contact	ANIL BHALANI Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2003
Decision Date	01/21/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review