Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K162655 |
Device Name |
StealthConnect Remote Viewing, Planning and Collaboration System |
Applicant |
MEDTRONIC NAVIGATION, INC. |
826 COAL CREEK CIRCLE |
LOUISVILLE,
CO
80027
|
|
Applicant Contact |
MONICA R. MONTANEZ |
Correspondent |
MEDTRONIC NAVIGATION, INC. |
826 COAL CREEK CIRCLE |
LOUISVILLE,
CO
80027
|
|
Correspondent Contact |
MONICA R. MONTANEZ |
Regulation Number | 882.4560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/23/2016 |
Decision Date | 04/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|