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
|
|
Correspondent Contact |
F. DAVID ROTHKOPF |
Regulation Number | 882.4400
|
Classification Product Code |
|
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
|
Recalls |
CDRH Recalls
|
|
|