Cleared Traditional

WALTER GRAPHTEK

K910972 · Inomed Medizintechnik GmbH · Neurology

Oct 1991

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K910972 is an FDA 510(k) clearance for the WALTER GRAPHTEK, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Inomed Medizintechnik GmbH (Emmendingen, DE). The FDA issued a Cleared decision on October 2, 1991, 209 days after receiving the submission on March 7, 1991. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K910972 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 1991
Decision Date	October 02, 1991
Days to Decision	209 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