FDA 510(k) Application Details - K022750

Device Classification Name	Continuous, Ventilator, Home Use   More FDA Info for this Device
510(K) Number	K022750
Device Name	Continuous, Ventilator, Home Use
Applicant	RESPIRONICS CALIFORNIA, INC. 2271 COSMOS CT. CARLSBAD, CA 92009 US Other 510(k) Applications for this Company
Contact	MARY FUNK Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	NOU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2002
Decision Date	11/20/2003
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