CEREGROTRAC

Full-montage Standard Electroencephalograph

ADVANCED INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Ceregrotrac.

Pre-market Notification Details

Device IDK842784
510k NumberK842784
Device Name:CEREGROTRAC
ClassificationFull-montage Standard Electroencephalograph
Applicant ADVANCED INSTRUMENTS, INC. SHORASHIM
ContactPhyllis Bellin
CorrespondentPhyllis Bellin
ADVANCED INSTRUMENTS, INC. SHORASHIM
Product CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-17
Decision Date1985-01-10

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