FDA 510(k) Application Details - K072385

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

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510(K) Number K072385
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant DIAGNOSTIC DEVICES PTY LTD
SUITE 405 OFFICE TOWER
WESTFIELD EASTGARDENS
EASTGARDENS 2036 AU
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Contact HARRY PLATT
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Regulation Number 870.2920

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Classification Product Code DXH
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Date Received 08/24/2007
Decision Date 01/11/2008
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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