FDA 510(k) Application Details - K112544

Device Classification Name Blood Pressure Cuff

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510(K) Number K112544
Device Name Blood Pressure Cuff
Applicant UNIMED MEDICAL SUPPLIES INC.
NO.37, YANSHAN ROAD, SHEKOU
SHENZHEN, GUANGDONG 518067 CN
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Contact XINMEI TAN
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 09/01/2011
Decision Date 11/22/2011
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 Y
Expedited Review



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