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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K122443
Device Name UFIT TEN-10
Original Applicant
9001 wesleyan rd, suite 200
indianapolis,  IN  46268
Original Contact allison scott, rac
Regulation Number870.1130
Classification Product Code
Date Received08/10/2012
Decision Date 11/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No