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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K982448
Device Name CARDIOLIGHT
Applicant
Capintec, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact MARY ANNE DELL
Correspondent
Capintec, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact MARY ANNE DELL
Regulation Number870.2800
Classification Product Code
DSH  
Date Received07/15/1998
Decision Date 06/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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