FDA 510(k) Application Details - K203620

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K203620
Device Name	Blood Pressure Cuff
Applicant	Wuxi Exanovo Medical Instrument Co., Ltd. No. 42, Xixin Road, Zhangjing, Xibei Town Wuxi 214194 CN Other 510(k) Applications for this Company
Contact	Xiao Huang Other 510(k) Applications for this Contact
Regulation Number	870.1120   More FDA Info for this Regulation Number
Classification Product Code	DXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2020
Decision Date	03/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review