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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 K760150
Device Name MONITOR, PATIENT (MODEL 78331A)
Original Applicant
HEWLETT-PACKARD CO.
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/01/1976
Decision Date 07/19/1976
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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