← Back to catalogue

Oxifirst Fetal Oxygen Saturation Monitoring System

FDA PMA

Class III (US FDA PMA)

PMA P990053

by Covidien llc

Identity

Trade Name
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM FDA PMA
Generic Name
Oximeter, fetal pulse FDA PMA

Identifiers

PMA Number
P990053 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 Oxifirst Fetal Oxygen Saturation Monitoring System is a fetal pulse oximeter designed for measuring oxygen saturation in fetuses during labor and delivery. It is classified under the generic name 'Oximeter, fetal pulse' and was developed by Covidien LLC.

This system received FDA Premarket Approval (PMA) under number P990053, with approval granted on May 12, 2000. It is intended for use in obstetric settings and is not described as sterile, single-use, or MRI-safe in the provided data.

Frequently asked questions

What type of device is the Oxifirst Fetal Oxygen Saturation Monitoring System?

The Oxifirst Fetal Oxygen Saturation Monitoring System is classified as a fetal pulse oximeter, which is a device used to measure the oxygen saturation level of a fetus during labor and delivery, based on its generic name and intended use in obstetrics.

Who manufactures the Oxifirst Fetal Oxygen Saturation Monitoring System?

The Oxifirst Fetal Oxygen Saturation Monitoring System is manufactured by Covidien LLC, as stated in the manufacturer and applicant fields of the device data.

What regulatory authorization does the Oxifirst Fetal Oxygen Saturation Monitoring System have?

The device has FDA Premarket Approval (PMA) under number P990053, with the decision date of May 12, 2000, and the decision code APWD indicating approval.

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. Sources consulted: Premarket Approval (PMA) - FDA, OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM ..., MMA · Oximeter, Fetal Pulse — FDA Product Code | Innolitics, OXIFIRST FETAL OXYGEN SATURATION MONITORING ..., OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Covidien llc
FDA Applicant
Covidien, LLC

Sources (1)

  • FDA PMA P990053 24 fields · synced Oct 6, 2026