Model M1310A Series 50T Fetal Telemetry System
by Hewlett-Packard Co. 510(k)
Active
510(k) K942887
Overview
The Model M1310A Series 50T Fetal Telemetry System is a perinatal monitoring device designed for continuous, non-invasive assessment of fetal heart rate and uterine contractions during pregnancy. It employs telemetry technology to transmit real-time data from external sensors placed on the mother’s abdomen to a central monitoring unit, enabling clinicians to evaluate fetal well-being and labor progression in obstetric settings.
This system is intended for use in clinical environments such as hospitals and birthing centers, where obstetricians and midwives monitor high-risk pregnancies or active labor. Supplied as a reusable medical device, it requires proper calibration and maintenance per manufacturer instructions. The system carries an FDA 510(k) clearance under product code HGM and regulation 884.2740, with no third-party involvement noted. Compliance with regulatory standards ensures safe integration into obstetric workflows.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942887 | Date15 Aug 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Hewlett-Packard Co.
Questions
What is the primary use of the M1310A Series 50T Fetal Telemetry System?
The M1310A Series 50T Fetal Telemetry System is designed for continuous, non-invasive monitoring of fetal heart rate and uterine contractions during pregnancy. It uses telemetry technology to transmit real-time data from external sensors placed on the mother’s abdomen to a central monitoring unit, enabling clinicians to assess fetal well-being and labor progression in obstetric settings like hospitals and birthing centers.
How is the M1310A Series 50T Fetal Telemetry System supplied and maintained?
This system is supplied as a reusable medical device. It requires proper calibration and maintenance as outlined in the manufacturer’s instructions to ensure accurate and reliable performance. Regular upkeep is essential for maintaining data integrity and device functionality in clinical environments.
Is the M1310A Series 50T Fetal Telemetry System single-use or reusable?
The M1310A Series 50T Fetal Telemetry System is designed for reusable use in clinical settings. Reusability helps reduce costs and environmental impact while maintaining the device’s performance for continuous monitoring of fetal health during pregnancy and labor.
What regulatory approval does the M1310A Series 50T Fetal Telemetry System hold?
The device holds FDA 510(k) clearance under product code HGM and regulation 884.2740, with a decision classification of substantially equivalent. This approval ensures it meets regulatory standards for use in obstetric monitoring, allowing safe integration into clinical workflows.
What clinical environments is the M1310A Series 50T Fetal Telemetry System intended for?
This system is specifically intended for use in clinical environments such as hospitals and birthing centers. It is particularly suited for monitoring high-risk pregnancies or active labor, where continuous assessment of fetal heart rate and uterine contractions is critical for patient safety and informed clinical decision-making.