FDA 510(k) Application Details - K211084

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K211084
Device Name	Blood Pressure Cuff
Applicant	Shanghai Caremate Medical Device Co. Ltd Building 4, No. 281, Hong An Road, Jinshan District, Shanghai 201503 CN Other 510(k) Applications for this Company
Contact	Mark Chu 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	04/12/2021
Decision Date	10/19/2021
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