The following data is part of a premarket notification filed by Abbott with the FDA for Ensite Velocity Cardiac Mapping System V5.2, Ensite Precision Cardiac Mapping System V2.2.
| Device ID | K183128 |
| 510k Number | K183128 |
| Device Name: | EnSite Velocity Cardiac Mapping System V5.2, EnSite Precision Cardiac Mapping System V2.2 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Abbott One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Cody Johnson |
| Correspondent | Cody Johnson Abbott One St. Jude Medical Drive St. Paul, MN 55117 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2018-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067030382 | K183128 | 000 |
| 05415067031471 | K183128 | 000 |
| 05415067030092 | K183128 | 000 |
| 05414734210546 | K183128 | 000 |
| 05414734210690 | K183128 | 000 |
| 05414734210553 | K183128 | 000 |