ENTERPRISE ELECTROPHYSIOLOGY SYSTEM


Device Classification Name

reduced- montage standard electroencephalograph

510(k) Number K110967
Device Name ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
Applicant
NEURALYNX INC
105 commercial drive
bozeman, 
MT 
59715 -2217

Applicant Contact mike johnson
Correspondent
NEURALYNX INC
105 commercial drive
bozeman, 
MT 
59715 -2217

Correspodent Contact mike johnson
Regulation Number 882.1400
Classification Product Code
OMC  
Date Received 04/06/2011
Decision Date 06/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No