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FDA 510(k) Application Details - K031557
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K031557
Device Name
Electrocardiograph
Applicant
SCHILLER AG
ALTGASSE 68
BAAR CH-6341 CH
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Contact
MARKUS BUETLER
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Regulation Number
870.2340
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Classification Product Code
DPS
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More FDA Info for this Product Code
Date Received
05/19/2003
Decision Date
04/14/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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