FDA 510(k) Application Details - K133009

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K133009
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	BMC MEDICAL CO., LTD 5/F Main Building No.19 Gucheng Street West,Shijingshan Beijing 100043 CN Other 510(k) Applications for this Company
Contact	MS. JINJING 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	09/25/2013
Decision Date	04/23/2014
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