FETAL SPIRAL ELECTRODE, MODEL FSE07000— 510(k) K030691
Substantially EquivalentClinical Innovations, Inc.
FDA 510(k) clearance K030691 for FETAL SPIRAL ELECTRODE, MODEL FSE07000, Substantially Equivalent on 2003-09-17. Applicant: Clinical Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Innovations, Inc.
- Product code
- Code HGP
- Device class
- Class 2
- Regulation
- 21 CFR 884.2675
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murray, UT, US
Recent devices under product code HGP
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Recalls naming K030691
K-number listed on FDA's recall record- Z-0908-2023 — Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
- Z-1250-2019 — Fetal Spiral Electrode, Model No. 9898 031 37631
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030691.
Data sourced from openFDA. This site is unofficial and independent of the FDA.