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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 K990113
Device Name DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
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
Recalls CDRH Recalls
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