FDA 510(k) Application Details - K093657

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

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510(K) Number K093657
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant ACIST MEDICAL SYSTEMS, INC.
7905 FULLER ROAD
EDEN PRAIRIE, MN 55344 US
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Contact AL SAALABI
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 11/25/2009
Decision Date 01/15/2010
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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