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Corometrics 120 Series Maternal/Fetal Monitor - Integrated Fetal Pulse Oximetry

by GE Medical Systems Information Technologies

PMA P000016510(k) K032252

Active United States

PMA, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK032252 Date21 Aug 2003IssuedStatusActive
United StatesFDA PMA PMA NumberP000016 Date9 Feb 2001ApprovedStatusWithdrawn

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k), FDA PMA Active

Specification

510(k) · PMA

Trade Name
Corometrics 120F Series Maternal/Fetal Monitor
Generic Name
Oximeter, fetal pulse
PMA Number
510(k) Number
FDA Product Code
HGM
Models / Variants
Integrated Fetal Pulse Oximetry
Device Class
Class II
Regulation
21 CFR Part 884.2740
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Corometrics 120 Series Maternal/Fetal Monitor is a medical system designed for continuous intrapartum fetal oxygen saturation monitoring. It functions as an adjunct to fetal heart rate monitoring, specifically intended for use when a nonreassuring fetal heart rate pattern is identified.

This system is designed for use on a singleton fetus in vertex presentation with a gestational age of 36 weeks or greater. It is intended for clinical application only after maternal membranes have ruptured. The system integrates fetal oxygen saturation monitoring, a fetal patient module, and the Nellcor OxiFirst FS14 sensor.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use of the Corometrics 120 Series?

    The device is used for continuous intrapartum fetal oxygen saturation monitoring. It serves as an adjunct to fetal heart rate monitoring when a nonreassuring heart rate pattern is detected.

  • Are there specific patient requirements for using this monitor?

    Yes, the monitor is indicated for use only on a singleton fetus in vertex presentation with a gestational age of 36 weeks or greater, and only after the maternal membranes have ruptured.

  • What components are included in the monitoring system?

    The system includes the maternal/fetal monitor, a fetal patient module, and the Nellcor OxiFirst FS14 sensor for oxygen saturation monitoring.