510(k) K030691 ยท HGP Electrode, Circular (Spiral), Scalp And Applicator
FETAL SPIRAL ELECTRODE, MODEL FSE07000
| Applicant | Clinical Innovations, Inc., Murray UT, US |
| Decision | Substantially Equivalent, Sep 17, 2003 |
| Received | Mar 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030691
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2023 | Philips North America Llc Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor.
PN: 989803137631 Open, Classified |
HGP | None listed |
| Jan 25, 2019 | Philips North America, LLC Fetal Spiral Electrode, Model No. 9898 031 37631 Terminated |
HGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.