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FDA 510(k) Application Details - K152040
Device Classification Name
Reduced- Montage Standard Electroencephalograph
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510(K) Number
K152040
Device Name
Reduced- Montage Standard Electroencephalograph
Applicant
ADVANCED BRAIN MONITORING, INC.
2237 FARADAY AVENUE, SUITE 100
CARLSBAD, CA 92008 US
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Contact
DANIEL J. LEVENDOWSKI
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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
07/22/2015
Decision Date
10/30/2015
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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