Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K212061 |
Device Name |
EnSite X EP System |
Applicant |
Abbott |
One St. Jude Medical Drive |
St. Paul,
MN
55117
|
|
Applicant Contact |
Jamie Glaser |
Correspondent |
Abbott |
One St. Jude Medical Drive |
St. Paul,
MN
55117
|
|
Correspondent Contact |
Jamie Glaser |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 07/01/2021 |
Decision Date | 10/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|