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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 K961401
Device Name HP CATHSTATION - MODEL M1264B
Original Applicant
HEWLETT-PACKARD CO.
3000 minuteman rd.
andover,  MA  01810 1085
Original Contact rob butler
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/11/1996
Decision Date 10/08/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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