FDA 510(k) Application Details - K210288

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K210288
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	Xiamen Compower Medical Tech. Co., Ltd. Unit 301, No.16, Xianghong Road, Xiang'An Torch Industrial Zone Xiamen 361101 CN Other 510(k) Applications for this Company
Contact	Lifen Chen Other 510(k) Applications for this Contact
Regulation Number	868.5915   More FDA Info for this Regulation Number
Classification Product Code	BTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2021
Decision Date	08/26/2021
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