The following data is part of a premarket notification filed by Abbott with the FDA for Ensite X Ep System.
| Device ID | K212061 |
| 510k Number | K212061 |
| Device Name: | EnSite X EP System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Abbott One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Jamie Glaser |
| Correspondent | Jamie Glaser 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 | 2021-07-01 |
| Decision Date | 2021-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067038098 | K212061 | 000 |
| 05415067037695 | K212061 | 000 |
| 05415067037701 | K212061 | 000 |
| 05415067037718 | K212061 | 000 |
| 05415067037725 | K212061 | 000 |
| 05415067037732 | K212061 | 000 |
| 05415067037749 | K212061 | 000 |
| 05415067037756 | K212061 | 000 |
| 05415067037763 | K212061 | 000 |
| 05415067037770 | K212061 | 000 |
| 05415067038111 | K212061 | 000 |