FDA 510(k) Application Details - K002074

Device Classification Name Electrocardiograph

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510(K) Number K002074
Device Name Electrocardiograph
Applicant H&C MEDICAL DEVICES SPA
VIA PISA 250
20099 SESTO SAN GIOVANNI
MILAN 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 07/10/2000
Decision Date 10/04/2000
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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