The following data is part of a premarket notification filed by Abbott Medical with the FDA for Ensite Velocity Cardiac Mapping System, Ensite Precision Cardiac Mapping System.
| Device ID | K201181 |
| 510k Number | K201181 |
| Device Name: | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Abbott Medical 5050 Nathan Lane North Nathan Lane North, MN 55442 |
| Contact | Charlie Pickrell |
| Correspondent | Charlie Pickrell Abbott Medical 5050 Nathan Lane North Nathan Lane North, MN 55442 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-30 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067033789 | K201181 | 000 |
| 05415067023230 | K201181 | 000 |
| 05415067018052 | K201181 | 000 |
| 05415067012258 | K201181 | 000 |
| 05415067008718 | K201181 | 000 |
| 05415067001825 | K201181 | 000 |
| 05414734210577 | K201181 | 000 |
| 05414734210256 | K201181 | 000 |
| 05414734031035 | K201181 | 000 |
| 05415067024732 | K201181 | 000 |
| 05415067027870 | K201181 | 000 |
| 05415067028174 | K201181 | 000 |
| 05415067032355 | K201181 | 000 |
| 05415067032300 | K201181 | 000 |
| 05415067031402 | K201181 | 000 |
| 05415067029799 | K201181 | 000 |
| 05415067029782 | K201181 | 000 |
| 05415067029775 | K201181 | 000 |
| 05415067029713 | K201181 | 000 |
| 05415067028181 | K201181 | 000 |
| 15415067041712 | K201181 | 000 |