NEMUS SYSTEM; NEMUS PC PERIPHERAL


Device Classification Name

electromyograph, diagnostic

510(k) Number K073415
Device Name NEMUS SYSTEM; NEMUS PC PERIPHERAL
Applicant
EB NEURO, S.P.A.
11460 n. meridian st.
suite 150
carmel, 
IN 
46032

Applicant Contact allison scott
Correspondent
EB NEURO, S.P.A.
11460 n. meridian st.
suite 150
carmel, 
IN 
46032

Correspodent Contact allison scott
Regulation Number 890.1375
Classification Product Code
IKN  
Subsequent Product Codes
GWF   GWJ   JXE  
Date Received 12/04/2007
Decision Date 05/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No