← Product Code [HGH](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH) · K840285

# NON STRESS TEST MONITOR 507 (K840285)

_Imex Medical Systems, Inc. · HGH · May 9, 1984 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH/K840285

## Device Facts

- **Applicant:** Imex Medical Systems, Inc.
- **Product Code:** [HGH](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH.md)
- **Decision Date:** May 9, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5070
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH/K840285](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH/K840285)

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