Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K082011 |
Device Name |
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 |
Applicant |
BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK WEST |
GALWAY,
IE
|
|
Applicant Contact |
ANNE-MARIE KEENAN |
Correspondent |
BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK WEST |
GALWAY,
IE
|
|
Correspondent Contact |
ANNE-MARIE KEENAN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/15/2008 |
Decision Date | 11/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|