PE-210AK SWITCH BOX


Device Classification Name

full-montage standard electroencephalograph

510(k) Number K110376
Device Name PE-210AK SWITCH BOX
Applicant
NIHON KOHDEN CORP.
90 icon street
foothill ranch, 
CA 
92610

Applicant Contact steve geerdes
Correspondent
NIHON KOHDEN CORP.
90 icon street
foothill ranch, 
CA 
92610

Correspodent Contact steve geerdes
Regulation Number 882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GYC  
Date Received 02/09/2011
Decision Date 07/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No