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FDA 510(k) Application Details - K152184
Device Classification Name
Magnetoencephalograph
More FDA Info for this Device
510(K) Number
K152184
Device Name
Magnetoencephalograph
Applicant
TRISTAN TECHNOLOGIES, INC
6191 CORNERSTONE CT., STE 107
SAN DIEGO, CA 92121 US
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Contact
KEVIN PRATT
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
OLY
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More FDA Info for this Product Code
Date Received
08/05/2015
Decision Date
04/08/2016
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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