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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K123996
Device Name RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
Applicant
Ge Medical Systems Information Technologies, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact MARY CARTER
Correspondent
Ge Medical Systems Information Technologies, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact MARY CARTER
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/26/2012
Decision Date 04/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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