FDA 510(k) Application Details - K020366

Device Classification Name Electrocardiograph

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510(K) Number K020366
Device Name Electrocardiograph
Applicant CARDIOCOMM SOLUTIONS, INC.
3060 CEDAR HILL RD., SUITE 201
VICTORIA, B.C. V8T 3J5 CA
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Contact ANGELA HALWAS
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 02/04/2002
Decision Date 04/30/2002
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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