FDA 510(k) Application Details - K992524

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

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510(K) Number K992524
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant ADVANTAGE MEDICAL ELECTRONICS, INC.
10630 WILES RD.
CORAL SPRINGS, FL 33076 US
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Contact KENNETH E KENDRICKS
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 07/28/1999
Decision Date 03/01/2000
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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