FDA 510(k) Application Details - K071751

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

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510(K) Number K071751
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant LIFESYNC CORPORATION
8282 SHADOWWOOD DRIVE
CORAL SPRINGS, FL 33071 US
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Contact DIANE SUDDUTH
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 06/28/2007
Decision Date 08/27/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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