SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
Device Facts
| Record ID | K003458 |
|---|---|
| Device Name | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 |
| Applicant | Clinical Innovations, Inc. |
| Product Code | HGP · Obstetrics/Gynecology |
| Decision Date | May 3, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2675 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular electrodes.
