GEODESIC EEG MOBILE 100 (GEM 100)— 510(k) K112353

Name: FDA 510(k) clearance K112353
Creator: U.S. Food and Drug Administration
Published: 2012-02-17

Substantially Equivalent

Electrical Geodesics, Inc.

FDA 510(k) clearance K112353 for GEODESIC EEG MOBILE 100 (GEM 100), Substantially Equivalent on 2012-02-17. Applicant: Electrical Geodesics, Inc.. Device class: 2.

Clearance details

Applicant: Electrical Geodesics, Inc.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2011-08-16
Decision date: 2012-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eugene, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWQ

view all

K261604 — Enobio Dx (3 models)2026-06-13
K260455 — New Wave System2026-03-13
K233403 — Flexset System2024-04-30
K231366 — Neuronaute Plus2023-11-09
K221959 — Q212023-08-31

More clearances from Electrical Geodesics, Inc.

view all

K131882 — GEODESICEEG SYSTEM 400 SERIES (GES 400)2014-02-12
K092844 — GEOSOURCE2010-12-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.