← Product Code [HGW](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW) · K810028

# FETAL BLOOD SAMPLING KIT MODEL 1560 (K810028)

_Transidyne General Corp. · HGW · Jan 16, 1981 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW/K810028

## Device Facts

- **Applicant:** Transidyne General Corp.
- **Product Code:** [HGW](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW.md)
- **Decision Date:** Jan 16, 1981
- **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/K810028](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW/K810028)

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