Device Classification Name |
software for visualization of vascular anatomy and intravascular devices
|
510(k) Number |
K212373 |
Device Name |
Sim&Size |
Applicant |
Sim&Cure |
95 rue Pierre Flourens Bâtiment H |
Montpellier,
FR
34090
|
|
Applicant Contact |
Caroline Oziel |
Correspondent |
Sim&Cure |
95 rue Pierre Flourens Bâtiment H |
Montpellier,
FR
34090
|
|
Correspondent Contact |
Lucile AZEMA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/30/2021 |
Decision Date | 01/27/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|