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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
Original Applicant
HEWLETT-PACKARD CO.
49 plain st.
north attleboro,  MA  02760
Original Contact james r veale
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/19/1997
Decision Date 03/18/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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