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Series 50 XMO (Model M1350C) Fetal/Maternal Monitor System with Integrated Fetal Oxygen Saturation Monitoring

FDA PMA

Class III (US FDA PMA)

PMA P020028

by Philips Medical Systems, Inc.

Identity

Trade Name
SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING FDA PMA
Generic Name
Oximeter, fetal pulse FDA PMA

Identifiers

PMA Number
P020028 FDA PMA
FDA Product Code
MMA FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Obstetrics/Gynecology FDA PMA
FDA Decision
APWD FDA PMA

The Series 50 XMO (Model M1350C) is a fetal/maternal monitor system with integrated fetal oxygen saturation monitoring. It is intended for continuous monitoring of intrapartum fetal oxygen saturation (FSpO2) as an adjunct to fetal heart rate monitoring in the presence of a nonreassuring fetal heart rate pattern.

This device should only be used after amniotic membranes have ruptured and on a singleton fetus in vertex presentation with a gestational age greater than or equal to 36 weeks. It includes the M1365A fetal SpO2 patient module and the Nellcor Oxifirst FS14 sensor, and is authorized under FDA PMA P020028.

Frequently asked questions

What is the intended use of the Series 50 XMO (Model M1350C) fetal/maternal monitor system?

The device is intended for continuous monitoring of intrapartum fetal oxygen saturation (FSpO2) as an adjunct to fetal heart rate (FHR) monitoring in the presence of a nonreassuring fetal heart rate pattern. It should only be used after amniotic membranes have ruptured and on a singleton fetus in vertex presentation with a gestational age greater than or equal to 36 weeks.

What components are included with the Series 50 XMO (Model M1350C) system?

The system includes the M1365A fetal SpO2 patient module and the Nellcor Oxifirst FS14 sensor, as specified in the approval documentation for the Series 50 XMO (Model M1350C) fetal/maternal monitor system with integrated fetal oxygen saturation monitoring.

What regulatory authorization does the Series 50 XMO (Model M1350C) have?

The device is authorized under FDA Premarket Approval (PMA) with PMA number P020028, as indicated in the device data under the AUTHORIZATIONS and pma_number fields.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Philips Medical Systems, Inc.

Sources (1)

  • FDA PMA P020028 24 fields · synced Oct 6, 2026