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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 K874421
Device Name PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
Applicant
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810 -1085
Applicant Contact DONALD A GUTHRIE
Correspondent
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810 -1085
Correspondent Contact DONALD A GUTHRIE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received10/28/1987
Decision Date 01/28/1988
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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