FDA 510(k) Application Details - K031416

Device Classification Name Blood Pressure Cuff

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510(K) Number K031416
Device Name Blood Pressure Cuff
Applicant CLEAR MEDICAL, INC.
1776 136TH PL. NE
BELLEVUE, WA 98005 US
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Contact LANE ABENROTH
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 05/05/2003
Decision Date 07/15/2003
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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