The following data is part of a premarket notification filed by Abbott Medical with the FDA for Ensite X Ep System.
| Device ID | K213364 |
| 510k Number | K213364 |
| Device Name: | EnSite X EP System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Abbott Medical 5050 Nathan Ln N Plymouth, MN 55442 |
| Contact | Tabitha Payne |
| Correspondent | Tabitha Payne Abbott Medical 5050 Nathan Ln N Plymouth, MN 55442 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-12 |
| Decision Date | 2021-11-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067046215 | K213364 | 000 |
| 05415067040770 | K213364 | 000 |