FDA 510(k) Application Details - K090014

Device Classification Name Blood Pressure Cuff

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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
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Contact XIAOMING HONG
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Regulation Number 870.1120

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Classification Product Code DXQ
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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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