FDA 510(k) Application Details - K123957

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K123957
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	SMITHS MEDICAL INTERNATIONAL LTD. BRAMINGHAM BUSINESS PARK ENTERPRISE WAY LUTON, BEDFORDSHIRE LU3 4BU GB Other 510(k) Applications for this Company
Contact	LORI BERENDS 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	12/21/2012
Decision Date	09/16/2013
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