FDA 510(k) Application Details - K190078

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

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510(K) Number K190078
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant Volcano Corporation
3721 Valley Ctrre Dr Ste 500
San Diego, CA 92130 US
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Contact Kimberly Simon
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 01/16/2019
Decision Date 02/11/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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