FDA 510(k) Application Details - K133117

Device Classification Name Blood Pressure Cuff

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510(K) Number K133117
Device Name Blood Pressure Cuff
Applicant ANDON HEALTH CO., LTD
No. 3 Jin Ping Street,Ya An Road,
NANKAI DISTRICT
TIANJIN 300190 CN
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Contact LIU YI
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 09/30/2013
Decision Date 03/04/2014
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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