NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A


Device Classification Name

non-normalizing quantitative electroencephalograph software

510(k) Number K080546
Device Name NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
Applicant
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch, 
CA 
92610 -1601

Applicant Contact jack coggan
Correspondent
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch, 
CA 
92610 -1601

Correspodent Contact jack coggan
Regulation Number 882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWQ   OLV  
Date Received 02/28/2008
Decision Date 08/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No