510(k) K210392 ยท DQK Computer, Diagnostic, Programmable
WorkMate Claris System
| Applicant | Abbott, St. Paul MN, US |
| Decision | Substantially Equivalent, Mar 11, 2021 |
| Received | Feb 10, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2021 | Abbott Laboratories Inc. (St Jude Medical) v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed fo Terminated |
DQK | None listed |
| May 5, 2021 | Abbott Laboratories Inc. (St Jude Medical) v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display,
Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system d Terminated |
DQK | None listed |
| May 5, 2021 | Abbott Laboratories Inc. (St Jude Medical) WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.