FDA 510(k) Application Details - K080063

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K080063
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. ST. LOUIS, MO 63110 US Other 510(k) Applications for this Company
Contact	WAYNE KARCHER 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	01/10/2008
Decision Date	08/15/2008
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