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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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More FDA Info for this Product Code
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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