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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K963578
Device Name PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)
Applicant
Intl. Products, Inc.
8106 Meadow Springs Ct.
Vienna,  VA  22182
Applicant Contact UWE KLOOTZ
Correspondent
Intl. Products, Inc.
8106 Meadow Springs Ct.
Vienna,  VA  22182
Correspondent Contact UWE KLOOTZ
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/06/1996
Decision Date 06/30/1997
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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