FDA 510(k) Application Details - K051534

Device Classification Name Electrocardiograph

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510(K) Number K051534
Device Name Electrocardiograph
Applicant ET MEDICAL DEVICES SPA
VIA DE ZINIS 6
CAVARENO 38011 IT
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Contact ATTILIO CASTELLI
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 06/10/2005
Decision Date 10/05/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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