FDA 510(k) Application Details - K002316

Device Classification Name Electroencephalograph

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510(K) Number K002316
Device Name Electroencephalograph
Applicant AXON SYSTEMS, INC.
400-2200 OSER AVE.
HAUPPAUGE, NY 11788 US
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Contact HOWARD BAILIN
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 07/31/2000
Decision Date 10/26/2000
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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