Device Classification Name |
Stimulator, Nerve
|
510(k) Number |
K071349 |
Device Name |
NEUROSIGN LARYNGEAL ELECTRODES |
Applicant |
THE MAGSTIM COMPANY LTD. |
SPRING GARDENS |
WHITLAND |
CARMARTHENSHIRE, WALES,
GB
SA34 OHR
|
|
Applicant Contact |
ANWEN EVANS |
Correspondent |
THE MAGSTIM COMPANY LTD. |
SPRING GARDENS |
WHITLAND |
CARMARTHENSHIRE, WALES,
GB
SA34 OHR
|
|
Correspondent Contact |
ANWEN EVANS |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 05/14/2007 |
Decision Date | 12/12/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|