MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)


Device Classification Name

electrode, cortical

510(k) Number K110410
Device Name MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
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 882.1310
Classification Product Code
GYC  
Subsequent Product Code
GWF  
Date Received 02/14/2011
Decision Date 08/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No