FDA 510(k) Application Details - K001467

Device Classification Name Stimulator, Photic, Evoked Response

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510(K) Number K001467
Device Name Stimulator, Photic, Evoked Response
Applicant AIRSEP CORP.
290 CREEKSIDE DR.
BUFFALO, NY 14228 US
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Contact PETER WEISENBORN
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Regulation Number 882.1890

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Classification Product Code GWE
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Date Received 05/10/2000
Decision Date 08/01/2000
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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