Device Classification Name |
ear, nose, and throat stereotaxic instrument
|
510(k) Number |
K170018 |
Device Name |
StealthStationTM S8 ENT Software |
Applicant |
Medtronic Navigation, Inc. |
826 Coal Creek Circle |
Louisville,
CO
80027
|
|
Applicant Contact |
K. Elizabeth Waite |
Correspondent |
Medtronic Navigation, Inc. |
826 Coal Creek Circle |
Louisville,
CO
80027
|
|
Correspondent Contact |
K. Elizabeth Waite |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 01/03/2017 |
Decision Date | 05/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|