FDA 510(k) Application Details - K123996

Device Classification Name Blood Pressure Cuff

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510(K) Number K123996
Device Name Blood Pressure Cuff
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact MARY CARTER
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 12/26/2012
Decision Date 04/09/2013
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

FDA Source Information for K123996


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