NT 2000 LESIONING GENERATOR


Device Classification Name

generator, lesion, radiofrequency

510(k) Number K111576
Device Name NT 2000 LESIONING GENERATOR
Applicant
NEUROTHERM, INC.
200 homer ave
ashland, 
MA 
01721

Applicant Contact f. david rothkopf
Correspondent
NEUROTHERM, INC.
200 homer ave
ashland, 
MA 
01721

Correspodent Contact f. david rothkopf
Regulation Number 882.4400
Classification Product Code
GXD  
Date Received 06/06/2011
Decision Date 09/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No