Device Classification Name |
neurological stereotaxic instrument
|
510(k) Number |
K231976 |
Device Name |
StealthStation Cranial Software, v3.1.5 (9735585) |
Applicant |
Medtronic Navigation, Inc. |
200 Medtronic Drive |
Lafayette,
CO
80026
|
|
Applicant Contact |
Rishi Mehta |
Correspondent |
Medtronic Navigation, Inc. |
200 Medtronic Drive |
Lafayette,
CO
80026
|
|
Correspondent Contact |
Rishi Mehta |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 07/03/2023 |
Decision Date | 10/19/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|