FDA 510(k) Application Details - K191492

Device Classification Name Electroencephalograph

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510(K) Number K191492
Device Name Electroencephalograph
Applicant Neurovirtual USA, INC.
3303 W Commercial Blvd #100
Fort Lauderdale, FL 33309 US
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Contact Eduardo Faria
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 06/05/2019
Decision Date 04/24/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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