Fetal & Maternal Monitor F15A, F15A Air
510(k) K241882
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241882 | Date27 Aug 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HGM
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2740
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Fetal & Maternal Monitor F15A, F15A Air is a System, Monitoring, Perinatal device designed for continuous assessment of fetal and maternal physiological parameters during pregnancy and labor. It provides real-time monitoring of fetal heart rate and uterine contractions, enabling clinicians to evaluate fetal well-being and detect potential complications such as hypoxia or abnormal labor patterns. The device integrates advanced algorithms to enhance accuracy and reliability in obstetric settings, supporting clinical decision-making throughout antepartum and intrapartum phases.
This device is intended for use in antepartum examination rooms, labor, and delivery rooms by trained personnel. Supplied as a reusable medical system, it requires proper calibration and maintenance per manufacturer guidelines. The F15A, F15A Air has received FDA 510K clearance under classification II (HGM product code) and adheres to regulatory standards for obstetric monitoring. Storage and handling follow standard medical device protocols to ensure functionality and sterility where applicable.
Other devices from Edan Instruments, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Fetal & Maternal Monitor F15A, F15A Air used for?
The Fetal & Maternal Monitor F15A, F15A Air is designed for continuous monitoring of fetal heart rate and uterine contractions during pregnancy and labor. It helps clinicians assess fetal well-being in real-time, detect complications like hypoxia or abnormal labor patterns, and support clinical decision-making in antepartum and intrapartum settings.
Is the Fetal & Maternal Monitor F15A, F15A Air reusable or single-use?
The Fetal & Maternal Monitor F15A, F15A Air is supplied as a reusable medical system. It requires proper calibration and maintenance as outlined in the manufacturer’s guidelines to ensure accurate and reliable performance over repeated use.
Where can the Fetal & Maternal Monitor F15A, F15A Air be used?
This device is intended for use in antepartum examination rooms, labor rooms, and delivery rooms. It is specifically designed for obstetric settings where continuous monitoring of fetal and maternal physiological parameters is required.
How does the Fetal & Maternal Monitor F15A, F15A Air enhance monitoring accuracy?
The device integrates advanced algorithms to improve the accuracy and reliability of fetal heart rate and uterine contraction monitoring. These algorithms help clinicians obtain clearer data, reducing the risk of misinterpretation and supporting more informed clinical decisions.
What regulatory clearance does the Fetal & Maternal Monitor F15A, F15A Air hold?
The Fetal & Maternal Monitor F15A, F15A Air has received FDA 510K clearance under classification II (HGM product code). This clearance confirms that the device meets regulatory standards for obstetric monitoring as determined by the FDA.