FDA 510(k) Application Details - K153251

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K153251
Device Name	Blood Pressure Cuff
Applicant	NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD. 24/F, 238 ZHONGSHAN EAST ROAD NINGBO 315010 CN Other 510(k) Applications for this Company
Contact	CHARLES SHEN 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	11/10/2015
Decision Date	04/14/2016
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