FDA 510(k) Application Details - K040090

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K040090
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	PNEUPAC LTD. N7 W22025 JOHNSON ROAD WAUKESHA, WI 53186 US Other 510(k) Applications for this Company
Contact	DONALD ALEXANDER 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	01/16/2004
Decision Date	05/27/2004
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