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Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A

FDA 510(k)

Class II (US FDA 510(k))

510(k) K023931

by Philips Medical Systems, Inc.

Identifiers

510(k) Number
K023931 FDA 510(k)
FDA Product Code
HGM FDA 510(k)
Models / Variants
M2720a FDA 510(k)
M2725a FDA 510(k)
M2726a FDA 510(k)
M2727a FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.2740 FDA 510(k)
Regulation Number
884.2740 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Philips Avalon CTS Cordless Fetal Transducer System is a Monitoring System, Perinatal designed for obstetric use. It employs cordless fetal transducers to continuously monitor fetal heart rate and uterine contractions during pregnancy, providing real-time data for assessing fetal well-being and labor progression. The system integrates wireless technology to eliminate cable constraints, enhancing patient mobility and comfort. Its primary function aligns with perinatal monitoring standards, ensuring accurate and reliable fetal assessment in clinical settings.

The system consists of a base station (Model M2720A) paired with interchangeable cordless transducers (Models M2725A, M2726A, M2727A) for fetal heart rate and tocodynamometry. Supplied as a reusable medical device, it requires proper calibration and maintenance as outlined in manufacturer service guidelines. The system is classified under FDA regulation 884.2740 and holds a FDA 510K clearance with a Substantially Equivalent determination by the Obstetrics/Gynecology Advisory Committee. Storage and handling follow standard medical device protocols to preserve functionality and ensure patient safety.

Frequently asked questions

What is the Philips Avalon CTS Cordless Fetal Transducer System used for?

The Philips Avalon CTS Cordless Fetal Transducer System is designed for obstetric use to continuously monitor fetal heart rate and uterine contractions during pregnancy and labor. This real-time data helps clinicians assess fetal well-being and track labor progression, ensuring accurate perinatal monitoring without the constraints of wired transducers.

How is the Philips Avalon CTS Cordless Fetal Transducer System supplied?

The system consists of a base station (Model M2720A) paired with interchangeable cordless transducers (Models M2725A, M2726A, M2727A) for fetal heart rate and tocodynamometry. It is supplied as a reusable medical device, requiring proper calibration and maintenance as outlined in the manufacturer’s service guidelines.

Is the Philips Avalon CTS Cordless Fetal Transducer System single-use or reusable?

The Philips Avalon CTS Cordless Fetal Transducer System is a reusable medical device. It is designed for repeated use in clinical settings, provided it undergoes regular calibration and maintenance to ensure accuracy and functionality.

What models are included in the Philips Avalon CTS Cordless Fetal Transducer System?

The system includes the base station (Model M2720A) and three interchangeable cordless transducer models: M2725A, M2726A, and M2727A. These transducers are tailored for specific monitoring functions, such as fetal heart rate and uterine contraction tracking.

How should the Philips Avalon CTS Cordless Fetal Transducer System be stored?

The system should be stored following standard medical device protocols to preserve functionality and ensure patient safety. This includes maintaining a clean, dry environment, protecting components from physical damage, and adhering to manufacturer guidelines for calibration and maintenance.

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: PHILIPS AVALON CTS M2720A SERVICE MANUAL Pdf Download, PDF Avalon CTS, PDF Avalon CTS Cordless Fetal Transducer System M2720A, Philips Avalon CTS M2720A Manuals | ManualsLib

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K023931 24 fields · synced Oct 1, 2026