FDA 510(k) Application Details - K981405

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K981405
Device Name Stimulator, Electrical, Evoked Response
Applicant OXFORD INSTRUMENTS, PLC.
MANOR WAY
OLD WOKING , SURREY 9022 0JU GB
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Contact JEFF HALL
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 04/20/1998
Decision Date 07/16/1998
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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