510(k) K990113 ยท DRX Electrode, Electrocardiograph
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
| Applicant | Maersk Medical A/S, Fort Worth TX, US |
| Decision | Substantially Equivalent, Dec 6, 1999 |
| Received | Jan 13, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2010 | ConvaTec Unilect ECG Electrodes
Unomedical, McAllen Texas.
Intended use:Cardiac monitoring Terminated |
DRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.