510(k) K991105 ยท DRX Electrode, Electrocardiograph
ECG ELECTRODE (VARIOUS)
| Applicant | Conmedcorp, Utica NY, US |
| Decision | Substantially Equivalent, Nov 26, 1999 |
| Received | Apr 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991105
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2003 | Conmed Corporation 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 uni Terminated |
DRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.