FDA 510(k) Application Details - K163464

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K163464
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	BMC MEDICAL.,LTD. ROOM 110 TOWER A FENGYU BUILDING, NO.115 FUCHENG RD Haidian 100036 CN Other 510(k) Applications for this Company
Contact	Jiang Huiqi 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	12/09/2016
Decision Date	09/05/2017
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