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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 K921048
Device Name BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST
Applicant
Colin Medical Instruments Corp.
5850 Farinon Dr.
San Antonio,  TX  78249
Applicant Contact ALAN P SCHWARTZ
Correspondent
Colin Medical Instruments Corp.
5850 Farinon Dr.
San Antonio,  TX  78249
Correspondent Contact ALAN P SCHWARTZ
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/04/1992
Decision Date 07/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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