FDA 510(k) Application Details - K030218

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

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510(K) Number K030218
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant MEDICAL MONITORS PTY., LTD.
SUITE 407, OFFICE TOWERS
EAST GARDENS, NSW 2036 AU
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Contact HARRY L PLATT
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Regulation Number 870.2920

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Classification Product Code DXH
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Date Received 01/21/2003
Decision Date 06/23/2003
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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