← Product Code [HGW](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW) · K831459

# FETAL BLOOD SAMPLING KIT #1560 (K831459)

_Transidyne General Corp. · HGW · Jun 30, 1983 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW/K831459

## Device Facts

- **Applicant:** Transidyne General Corp.
- **Product Code:** [HGW](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW.md)
- **Decision Date:** Jun 30, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1560
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A fetal blood sampler is a device used to obtain fetal blood transcervically through an endoscope by puncturing the fetal skin with a short blade and drawing blood into a heparinized tube. The fetal blood pH is determined and used in the diagnosis of fetal distress and fetal hypoxia.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW/K831459](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW/K831459)

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