← Product Code [HFM](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM) · K893770

# TERM GUARD II DEVICE (K893770)

_Tokos Medical Corp. · HFM · Nov 3, 1989 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K893770

## Device Facts

- **Applicant:** Tokos Medical Corp.
- **Product Code:** [HFM](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM.md)
- **Decision Date:** Nov 3, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.2720
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K893770](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K893770)

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