NEUROMAP WITH NEURO 100


definition

Device Classification Name

stimulator, electrical, evoked response

510(k) Number K002773
Device Name NEUROMAP WITH NEURO 100
Original Applicant
RADIONICS, INC.
22 terry ave.
burlington, 
MA 
01803

Original Contact nancy c macdonald
Regulation Number 882.1870
Classification Product Code
GWF  
Subsequent Product Code
GWQ  
Date Received 09/06/2000
Decision Date 10/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No