GEODESIC EEG MOBILE 100 (GEM 100)


Device Classification Name

full-montage standard electroencephalograph

510(k) Number K112353
Device Name GEODESIC EEG MOBILE 100 (GEM 100)
Applicant
ELECTRICAL GEODESICS, INC.
29611 simmons road
eugene, 
OR 
97405

Applicant Contact linda j bovard
Correspondent
ELECTRICAL GEODESICS, INC.
29611 simmons road
eugene, 
OR 
97405

Correspodent Contact linda j bovard
Regulation Number 882.1400
Classification Product Code
GWQ  
Date Received 08/16/2011
Decision Date 02/17/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No