EEG-1100A SWITCH BOX


Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K073491
Device Name EEG-1100A SWITCH BOX
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
OLV  
Subsequent Product Code
GWQ  
Date Received 12/12/2007
Decision Date 01/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No