Multi-Prong Fetal Scalp Electrode
FDA 510(k) K822584 · Kontron Instruments, Inc.
510(k) numberK822584
Submission
- Device name
- Multi-Prong Fetal Scalp Electrode
- Applicant
- Kontron Instruments, Inc.
Walker, MI, US - Received
- August 26, 1982
- Decision date
- February 24, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K030691 | Fetal Spiral Electrode, Model FSE07000HGP · Traditional | Clinical Innovations, Inc. | 09/17/2003SE |
| 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 |
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|---|---|---|
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| K932268 | Modifications to Intra-Aortic BalloonsDSP · Traditional | 12/15/1993SE |
| K925248 | Modification of Intra-Aortic Balloon CathetersDSP · Traditional | 09/27/1993SE |
| K923603 | Intra-Aortic Balloon Pump Catheter - ModificationDYB · Traditional | 03/08/1993SE |
| K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat IIDSP · Traditional | 06/19/1991SE |
| K903344 | 9.5 FR Percutaneous DB Lumen 40CC Flexi-Cath (TM)DSP · Traditional | 01/15/1991SE |
| K896437 | Kontron Sigma 44 HVCD Ultrasound Imaging SystemDPT · Traditional | 12/03/1990SE |
| K892222 | 9.5F Percu Double Lumen Intra-Aortic BalloonDSP · Traditional | 09/14/1990SE |
| K882955 | Supermon Neonatal Non-Invasive Blood Press. 7283DXN · Traditional | 01/26/1990SE |
| K896386 | Minimon 7133B Patient MonitorDPS · Traditional | 12/13/1989SE |
Questions and answers
When was Multi-Prong Fetal Scalp Electrode cleared by the FDA?
Multi-Prong Fetal Scalp Electrode (K822584) received a 510(k) decision of Substantially Equivalent on February 24, 1983, 182 days after the submission was received.
What is the product code of K822584?
The FDA product code is HGP – Electrode, Circular (Spiral), Scalp And Applicator, a Class II (moderate risk) device regulated under 21 CFR 884.2675.