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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Synchronizer, Electrocardiograph, Nuclear
510(k) Number K853737
Device Name VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)
Applicant
Capintec, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact JOEL ORLINSKY
Correspondent
Capintec, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact JOEL ORLINSKY
Regulation Number892.1410
Classification Product Code
IYY  
Date Received09/06/1985
Decision Date 02/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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