Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K002869 |
Device Name |
LOCALISA CARDIAC NAVIGATION SYSTEM |
Applicant |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
3850 VICTORIA ST. NORTH |
SHOREVIEW,
MN
55126
|
|
Applicant Contact |
THOMAS PARKER |
Correspondent |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
3850 VICTORIA ST. NORTH |
SHOREVIEW,
MN
55126
|
|
Correspondent Contact |
THOMAS PARKER |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 09/13/2000 |
Decision Date | 03/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|