FDA 510(k) Application Details - K051476

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K051476
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 WEST CALDWELL, NJ 07006-0508 US Other 510(k) Applications for this Company
Contact	LESLIE H SHERMAN Other 510(k) Applications for this Contact
Regulation Number	868.5925   More FDA Info for this Regulation Number
Classification Product Code	BTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2005
Decision Date	10/28/2005
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