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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 K032857
Device Name PRESS-MATE BX-10 VITAL SIGN MONITOR
Applicant
Colin Medical Instruments Corp.
5850 Farinon Dr.
San Antonio,  TX  78249
Applicant Contact MARK RISON
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DQA  
Date Received09/12/2003
Decision Date 02/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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