FDA 510(k) Application Details - K031557

Device Classification Name Electrocardiograph

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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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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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