Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K201094 |
Device Name |
iMap 3D Mapping & Navigation System (iMap System) |
Applicant |
CardioNXT, Inc. |
12011 Tejon Street, Suite 700 |
Westminster,
CO
80234
|
|
Applicant Contact |
Kirk Mackin |
Correspondent |
CardioNXT, Inc. |
12011 Tejon Street, Suite 700 |
Westminster,
CO
80234
|
|
Correspondent Contact |
Jerome R Edwards |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 04/24/2020 |
Decision Date | 08/16/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|