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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 K974746
Device Name M1765A ECG MANAGER
Applicant
HEWLETT-PACKARD CO.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact JAMES R VEALE
Correspondent
HEWLETT-PACKARD CO.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact JAMES R VEALE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/19/1997
Decision Date 03/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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