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FDA 510(k) Application Details - K133419
Device Classification Name
Magnetoencephalograph
More FDA Info for this Device
510(K) Number
K133419
Device Name
Magnetoencephalograph
Applicant
TRISTAN TECHNOLOGIES INC
3365 CALLE MARGARITA
ENCINITAS, CA 92024 US
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Contact
EUGENE HIRSCHKOFF
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/07/2013
Decision Date
07/21/2014
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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