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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 K960449
Device Name PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)
Original Applicant
BIOSENSOR CORP.
13755 first avenue north
plymouth,  MN  55441
Original Contact b.steven springrose
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/30/1996
Decision Date 05/30/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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