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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 K954066
Device Name MINISCOPE MS-3
Original Applicant
3002 dow ave., #138
tustin,  CA  92780
Original Contact markus maritz
Regulation Number870.2340
Classification Product Code
Date Received08/30/1995
Decision Date 10/27/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No