Cleared Traditional

CEREGROTRAC

K842784 · Advanced Instruments, Inc. · Neurology
Jan 1985
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K842784 is an FDA 510(k) clearance for the CEREGROTRAC, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Advanced Instruments, Inc.. The FDA issued a Cleared decision on January 10, 1985, 177 days after receiving the submission on July 17, 1984. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K842784 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1984
Decision Date January 10, 1985
Days to Decision 177 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GWQ — Full-montage Standard Electroencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations