FDA 510(k) Application Details - K960515

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K960515
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	PNEU PAC, LTD. CRESCENT RD. LUTON BEDS LU2 OAH GB Other 510(k) Applications for this Company
Contact	NORMAN S JONES, PH.D. 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	02/05/1996
Decision Date	10/10/1996
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