The following data is part of a premarket notification filed by Abbott with the FDA for Ensite X Ep System.
| Device ID | K221213 |
| 510k Number | K221213 |
| Device Name: | EnSite X EP System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Abbott One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Alexandra Agre |
| Correspondent | Alexandra Agre Abbott One St. Jude Medical Drive St. Paul, MN 55117 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-27 |
| Decision Date | 2022-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067046710 | K221213 | 000 |
| 05415067046666 | K221213 | 000 |
| 05415067042460 | K221213 | 000 |
| 05415067042477 | K221213 | 000 |
| 05415067042507 | K221213 | 000 |
| 05415067046642 | K221213 | 000 |
| 05415067046680 | K221213 | 000 |
| 05415067046697 | K221213 | 000 |
| 05415067046703 | K221213 | 000 |
| 05415067041722 | K221213 | 000 |