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philips avalon fetal monitors fm20 fm30 fm40 and fm50
Philips Medizin Systeme Boeblingen
Summary: The Philips Avalon Fetal Monitors (FM20, FM30, FM40, FM50) are used for monitoring fetal and maternal parameters during pregnancy and labor. They are primarily used by obstetricians and midwives in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K092028 ↗
Decision Date
February 17, 2010
Product Code
HGM
Device Class
Class 2
Evidence
419 studies
The Philips Avalon Fetal Monitors were cleared via the FDA 510k pathway on February 17, 2010. Manufactured by Philips Medizin Systeme Boeblingen, these devices are classified as Class 2 under product code HGM.
What It Is
The Philips Avalon Fetal Monitors are advanced medical devices designed to track fetal heart rate, uterine contractions, and maternal vital signs. They use non-invasive techniques such as ultrasound and tocodynamometry to provide continuous monitoring, ensuring the safety and well-being of both mother and fetus during labor and delivery.
Clinical Applications
These monitors are commonly used in obstetric departments for antepartum and intrapartum monitoring. They are essential in high-risk pregnancies, allowing clinicians to detect fetal distress and manage labor effectively. The devices are suitable for use in hospital labor and delivery units, providing real-time data to guide clinical decisions.
Indications for Use
The FDA indications suggest that these monitors are intended for use in monitoring fetal and maternal conditions during pregnancy and labor. They are particularly useful for tracking fetal heart rate patterns and uterine activity, which are critical for assessing fetal well-being.
Practical Considerations
The Philips Avalon Fetal Monitors are compatible with various transducers and can be integrated into hospital information systems. They are available in different models to suit specific clinical needs, with features like touchscreen interfaces and wireless connectivity for ease of use.
Related Literature
The linked study investigated the impact of noise levels from nonstress test devices on stress parameters in first-time pregnant women. Although the abstract is not available, such studies typically focus on how device noise might affect patient comfort and stress levels. Limitations may include a small sample size or lack of detailed outcome measures.
Linked Studies (20)
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Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
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Comparative connectomics of Drosophila descending and ascending neurons.
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Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
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PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
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A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
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RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Philips Avalon Fetal Monitors used for?
They are used for monitoring fetal heart rate, uterine contractions, and maternal vital signs during pregnancy and labor.
What specialties typically use this device?
Obstetrics and midwifery specialties commonly use these monitors in hospital labor and delivery settings.
What are the FDA-cleared indications?
The monitors are indicated for tracking fetal and maternal conditions during pregnancy and labor, focusing on fetal heart rate and uterine activity.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.