FDA 510(k) Application Details - K952294

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K952294
Device Name Stimulator, Electrical, Evoked Response
Applicant COMPUTATIONAL DIAGNOSTICS, INC.
5001 BAUM BLVD., SUITE 426
PITTSBURGH, PA 15213 US
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Contact SHARON ENOS
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 05/16/1995
Decision Date 01/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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