| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K013081 |
| Device Name |
MEDSTAR 150 |
| Applicant |
| Mednet Services, Inc. |
| 2855 Anthony Ln. S., #B10 |
|
St. Anthony,
MN
55418
|
|
| Applicant Contact |
DAVID L MATHEWS |
| Correspondent |
| Mednet Services, Inc. |
| 2855 Anthony Ln. S., #B10 |
|
St. Anthony,
MN
55418
|
|
| Correspondent Contact |
DAVID L MATHEWS |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 09/14/2001 |
| Decision Date | 11/20/2001 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|