FDA 510(k) Application Details - K200674

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

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510(K) Number K200674
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant Atrility Medical, LLC
313 Price Place, Suite 13
Madison, WI 53705 US
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Contact Matthew Knoespel
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 03/16/2020
Decision Date 07/02/2020
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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