FDA 510(k) Application Details - K150111

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K150111
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	APEX MEDICAL CORP. NO. 9, MIN SHENG ST., TU-CHENG DISTRICT NEW TAIPEI COUNTY 23679 TW Other 510(k) Applications for this Company
Contact	Frank Lin 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	01/20/2015
Decision Date	09/15/2015
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