FDA 510(k) Application Details - K171889

Device Classification Name Blood Pressure Cuff

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510(K) Number K171889
Device Name Blood Pressure Cuff
Applicant Suzhou Minhua Medical Apparatus Supplies Co., LTD
You Yi Industrial Park, Songlin Town, Wujiang
Suzhou 215222 CN
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Contact Yang Qidong
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 06/26/2017
Decision Date 12/19/2017
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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