Device Classification Name |
stimulator, neuromuscular, external functional
|
510(k) Number |
K171396 |
Device Name |
ODFS Pace XL |
Applicant |
Odstock Medical Ltd |
Salisbury District Hospital |
Salisbury,
GB
SP2 8BJ
|
|
Applicant Contact |
Steven Crook |
Correspondent |
Odstock Medical Ltd |
Salisbury District Hospital |
Salisbury,
GB
SP2 8BJ
|
|
Correspondent Contact |
Steven Crook |
Regulation Number | 882.5810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/11/2017 |
Decision Date | 01/31/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|