COMPUMEDICS NEUVO


Device Classification Name

full-montage standard electroencephalograph

510(k) Number K081151
Device Name COMPUMEDICS NEUVO
Applicant
COMPUMEDICS USA, LTD.
6605 west wt harris blvd
suite f
charlotte, 
NC 
28269

Applicant Contact david cardona
Regulation Number 882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWE   GWF   GWJ  
Date Received 04/23/2008
Decision Date 09/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party Yes

Combination Product

No