Fetal Spiral Electrode, Model FSE07000
FDA 510(k) K030691 · Clinical Innovations, Inc.
510(k) numberK030691
Submission
- Device name
- Fetal Spiral Electrode, Model FSE07000
- Applicant
- Clinical Innovations, Inc.
Murray, UT, US - Received
- March 5, 2003
- Decision date
- September 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HGP – Electrode, Circular (Spiral), Scalp And Applicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2675
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)HGP · Traditional | Neoventa Medical AB | 01/17/2025SE |
| K003458 | Soft Beat Fetal Heart Rate Electrode Model SBT-7000HGP · Traditional | Clinical Innovations, Inc. | 05/03/2001SE |
| K943732 | Life Trace Fetal Spiral Electrode with Maternal ReferenceHGP · Traditional | Graphic Controls Corp. | 10/20/1994SE |
| K910815 | CR Spiral ElectrodeHGP · Traditional | Neward Enterprises, Inc. | 12/10/1991SE |
| K911657 | Fetal Scalp Spiral ElectrodeHGP · Traditional | Advanced Medical Systems, Inc. | 07/11/1991SE |
| K905830 | Combo Fetal Scalp Electrode/LegplateHGP · Traditional | Utah Medical Products, Inc. | 03/29/1991SE |
| K905130 | Fetal Monitoring Spiral ElectrodeHGP · Traditional | Graphic Controls Corp. | 01/29/1991SE |
| K904745 | Medi-Trace(R) Fetal Monitoring Spiral ElectrodeHGP · Traditional | Graphic Controls Corp. | 01/29/1991SE |
| K901152 | Redyplate Disposable Leg PlateHGP · Traditional | Medical Accessories, Inc. | 04/04/1990SE |
| K872057 | Fetal Scalp ElectrodeHGP · Traditional | Medical Accessories, Inc. | 11/16/1987SE |
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| K140163 | Koala TocoHFM · Traditional | 05/29/2014SE |
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Questions and answers
When was Fetal Spiral Electrode, Model FSE07000 cleared by the FDA?
Fetal Spiral Electrode, Model FSE07000 (K030691) received a 510(k) decision of Substantially Equivalent on September 17, 2003, 196 days after the submission was received.
What is the product code of K030691?
The FDA product code is HGP – Electrode, Circular (Spiral), Scalp And Applicator, a Class II (moderate risk) device regulated under 21 CFR 884.2675.