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FDA 510(k) Application Details - K090014
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K090014
Device Name
Blood Pressure Cuff
Applicant
CAREMATE MEDICAL DEVICE CO., LTD
SUITE 8D, NO. 19, LANE 999
ZHONGSHAN NO.2 ROAD(S)
SHANGHAI 200030 CN
Other 510(k) Applications for this Company
Contact
XIAOMING HONG
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
01/02/2009
Decision Date
04/09/2009
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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