FDA 510(k) Application Details - K192177

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K192177
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	SysMed (China) Co., Ltd 11-2-3 No. 17 Wensu Str., Hunnan New Dis. Shenyang 110171 CN Other 510(k) Applications for this Company
Contact	Yue Jian 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	08/12/2019
Decision Date	11/25/2020
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