FDA 510(k) Application Details - K070609

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K070609
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	03/05/2007
Decision Date	05/04/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review