FDA 510(k) Application Details - K221959

Device Classification Name Electroencephalograph

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510(K) Number K221959
Device Name Electroencephalograph
Applicant NeuroField Inc.
386 West Lane
Bishop, CA 93514 US
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Contact Nicholas J. Dogris
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 07/05/2022
Decision Date 08/31/2023
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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