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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 K873442
Device Name ECG ELECTRODE SYSTEM
Applicant
Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S
34 Madison St.
Cambridge,  MA  02138
Applicant Contact RIKK I LARSEN
Correspondent
Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S
34 Madison St.
Cambridge,  MA  02138
Correspondent Contact RIKK I LARSEN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received08/27/1987
Decision Date 11/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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