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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
Applicant
Biosign Technologies, Inc.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Applicant Contact ALLISON SCOTT, RAC
Correspondent
Biosign Technologies, Inc.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact ALLISON SCOTT, RAC
Regulation Number870.1130
Classification Product Code
DXN  
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
Predetermined Change
Control Plan Authorized		 No
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