FDA 510(k) Application Details - K211155

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K211155
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	BMC Medical Co., Ltd. Room 901, Building 1, No. 28 Pingguoyuan Road Beijing 100041 CN Other 510(k) Applications for this Company
Contact	Amy Wang 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	04/19/2021
Decision Date	03/09/2022
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