FDA 510(k) Application Details - K043495

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K043495
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	SMITHS MEDICAL INTERNATIONAL LTD., LUTON N7 W22025 JOHNSON DRIVE 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	12/17/2004
Decision Date	04/22/2005
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