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FDA 510(k) Application Details - K171414
Device Classification Name
Normalizing Quantitative Electroencephalograph Software
More FDA Info for this Device
510(K) Number
K171414
Device Name
Normalizing Quantitative Electroencephalograph Software
Applicant
Brainmaster Technologies, Inc.
195 Willis Street, Suite 3
Bedford, OH 44146 US
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Contact
Tom Collura
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
OLU
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More FDA Info for this Product Code
Date Received
05/15/2017
Decision Date
07/01/2018
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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