Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K162309 |
Device Name |
StealthStation S8 System Platforms and StealthStation Cranial Software |
Applicant |
MEDTRONIC NAVIGATION, INC. |
826 COAL CREEK CIRCLE |
LOUISVILLE,
CO
80027
|
|
Applicant Contact |
Tia Fushimi-Bain |
Correspondent |
MEDTRONIC NAVIGATION, INC. |
826 COAL CREEK CIRCLE |
LOUISVILLE,
CO
80027
|
|
Correspondent Contact |
Tia Fushimi-Bain |
Regulation Number | 882.4560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/17/2016 |
Decision Date | 03/31/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|