Cleared Traditional

K150498 - Discovery 24
(FDA 510(k) Clearance)

K150498 · Brainmaster Technologies, Inc. · Neurology
Jan 2016
Decision
334d
Days
Class 2
Risk

K150498 is an FDA 510(k) clearance for the Discovery 24, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Brainmaster Technologies, Inc. (Bedford, US). The FDA issued a Cleared decision on January 26, 2016, 334 days after receiving the submission on February 26, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K150498 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2015
Decision Date January 26, 2016
Days to Decision 334 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

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