FDA 510(k) Application Details - K003927

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K003927
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	CHEEN HOUNG ENT. CO. LTD. 23 ALLEY 11 LANE 65 SAN DREEN STREET TAIPEI (SHULIN) 23805 TW Other 510(k) Applications for this Company
Contact	JAY WANG Other 510(k) Applications for this Contact
Regulation Number	868.5915   More FDA Info for this Regulation Number
Classification Product Code	BTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2000
Decision Date	06/26/2001
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