Cleared Traditional

ACTILLUME

K894044 · Ambulatory Monitoring, Inc. · Neurology

Dec 1989

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K894044 is an FDA 510(k) clearance for the ACTILLUME, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Ambulatory Monitoring, Inc. (Ardsley, US). The FDA issued a Cleared decision on December 22, 1989, 198 days after receiving the submission on June 7, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K894044 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 1989
Decision Date	December 22, 1989
Days to Decision	198 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