FDA 510(k) Application Details - K062577

Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)

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510(K) Number K062577
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant TZ MEDICAL, INC.
7272 S.W. DURHAM RD., #800
PORTLAND, OR 97224 US
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Contact MADALYN DUNCAN
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 08/31/2006
Decision Date 12/15/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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