FDA 510(k) Application Details - K103174

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K103174
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	APEX MEDICAL CORP. NO. 9, MINSHENG STREET TUCHENG CITY, TAIPEI COUNTY 236 TW Other 510(k) Applications for this Company
Contact	ALAN CHANG Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2010
Decision Date	05/06/2011
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