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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 K031557
Device Name CARDIOVIT AT-102
Original Applicant
SCHILLER AG
altgasse 68
baar,  SZ ch-6341
Original Contact markus buetler
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/13/2003
Decision Date 04/14/2004
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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