510(k) K183266 ยท DQK Computer, Diagnostic, Programmable
EP-TRACER System
| Applicant | Schwarzer Cardiotek GmbH, Heilbronn, DE |
| Decision | Substantially Equivalent, Mar 1, 2019 |
| Received | Nov 23, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183266
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2022 | CardioTek BV CardioTek EP-TRACER Software V2.x. Completed |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.