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FDA 510(k) Application Details - K151290
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K151290
Device Name
Blood Pressure Cuff
Applicant
XUZHOU MAICUFF TECHNOLOGY CO.,LTD.
8#-2-1106, JINXIUJIAYUAN, JIANGUO WEST ROAD
XUZHOU 221006 CN
Other 510(k) Applications for this Company
Contact
LI ZHAOQIAN
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
05/15/2015
Decision Date
06/30/2015
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
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