FDA 510(k) Application Details - K020899

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K020899
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	PNEU PAC, LTD. SMITHS MEDICAL N7 W22025 JOHNSON ROAD WAUKESHA, WI 53186-1856 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	03/20/2002
Decision Date	12/13/2002
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