The following data is part of a premarket notification filed by Abbott Medical with the FDA for Ensite Precision Cardiac Mapping System V2.6, Ensite Precision Software Installation V2.6, Ensite Liveview Dynamic Display Software License.
| Device ID | K201148 |
| 510k Number | K201148 |
| Device Name: | EnSite Precision Cardiac Mapping System V2.6, EnSite Precision Software Installation V2.6, EnSite LiveView Dynamic Display Software License |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Abbott Medical One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Alyssa Timmers |
| Correspondent | Alyssa Timmers Abbott Medical 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 | 2020-04-29 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067033185 | K201148 | 000 |
| 05415067033178 | K201148 | 000 |
| 05415067046185 | K201148 | 000 |
| 05415067035004 | K201148 | 000 |
| 05415067046802 | K201148 | 000 |