510(k) K080112 ยท DSA Cable, Transducer And Electrode, Patient, (Including Connector)
PATIENT CABLE
| Applicant | Med-Dyne, Louisville KY, US |
| Decision | Substantially Equivalent, Jun 20, 2008 |
| Received | Jan 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2019 | GN Otometrics Gold Cup Leadwire and Snap Leadwire with the following component descriptions:
1. 24" Snap Leadwire, Blue;
2. 40" Snap Leadwire, Blue;
3. 24" Snap Leadwire, Red;
4. 40" Snap Leadwire, Red; Open, Classified |
DSA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.