FDA 510(k) Application Details - K212416

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K212416
Device Name	Blood Pressure Cuff
Applicant	Wenzhou Xikang Medical Instruments Co., Ltd No.1478 Haining Road, Haibin Street, Longwan District Wenzhou 325024 CN Other 510(k) Applications for this Company
Contact	Wang Tiance 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	08/03/2021
Decision Date	05/18/2022
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