C2 NERVEMONITOR SYSTEM WITH ACCESSORIES


Device Classification Name

stimulator, electrical, evoked response

510(k) Number K111647
Device Name C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
Applicant
INOMED MEDIZINTECHNIK GMBH
im hausgruen 29
emmendingen, 

DE

79312

Applicant Contact saschka busch
Correspondent
INOMED MEDIZINTECHNIK GMBH
im hausgruen 29
emmendingen, 

DE

79312

Correspodent Contact saschka busch
Regulation Number 882.1870
Classification Product Code
GWF  
Subsequent Product Code
ETN  
Date Received 06/13/2011
Decision Date 10/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No