FDA 510(k) Application Details - K021390

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K021390
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	CHEEN HOUNG ENT. CO. LTD. 23 SAN DREEN ST., ALLEY 11, LANE 65 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	05/02/2002
Decision Date	10/04/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review