FDA 510(k) Application Details - K122879

Device Classification Name Device, Biofeedback

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510(K) Number K122879
Device Name Device, Biofeedback
Applicant EEG SOFTWARE LLC
17625 MAYALL STREET
NORTHRIDGE, CA 91325 US
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Contact HOWARD LIGHTSTONE
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Regulation Number 882.5050

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Classification Product Code HCC
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Date Received 09/19/2012
Decision Date 02/06/2013
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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