510(k) K161245 ยท DQK Computer, Diagnostic, Programmable
EP-TRACER System
| Applicant | Cardio Tek, BV, Ae Maastricht-Airport Limburg, NL |
| Decision | Substantially Equivalent, Aug 5, 2016 |
| Received | May 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161245
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2017 | CardioTek BV CardioTek EP-TRACER Software V1.x and V2.0
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during el Completed |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.