FDA 510(k) Application Details - K024245

Device Classification Name Reduced- Montage Standard Electroencephalograph

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510(K) Number K024245
Device Name Reduced- Montage Standard Electroencephalograph
Applicant MENNEN MEDICAL LTD.
4 HAYARDEN ST., YAVNE
P.O. BOX 102
REHOVOT 76100 IL
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Contact EREZ NIMROD
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Regulation Number 882.1400

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Classification Product Code OMC
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Date Received 12/23/2002
Decision Date 05/10/2004
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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