Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 — St Jude Medical (510(k) K160187)
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 — St Jude Medical (510(k) K160187) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0; Applicant: St Jude Medical; Clearance track: 510(k)
| Device name | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 |
|---|---|
| Applicant | St Jude Medical |
| Clearance track | 510(k) |
| Submission number | K160187 |
| Decision | Substantially Equivalent |
| Decision date | 2016-10-21 |
| Date received | 2016-01-27 |
| Product code | DQK |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | MN, US |
| Source | openFDA device |
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$1999/mo
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