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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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More FDA Info for this Product Code
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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