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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K990111
Device Name DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
Applicant
MAERSK MEDICAL A/S
6401 MEADOWS WEST
FORT WORTH,  TX  76132
Applicant Contact RICHARD A HAMER
Correspondent
MAERSK MEDICAL A/S
6401 MEADOWS WEST
FORT WORTH,  TX  76132
Correspondent Contact RICHARD A HAMER
Regulation Number870.2360
Classification Product Code
DRX  
Date Received01/13/1999
Decision Date 12/06/1999
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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