510(k) K792669 ยท HGP Electrode, Circular (Spiral), Scalp And Applicator
COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE
| Applicant | Ge Medical Systems Information Technologies, Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 11, 1980 |
| Received | Dec 27, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K792669
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2012 | Vital Signs Devices, a GE Healthcare Company Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0
A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery Terminated |
HGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.