Model 855 Enhanced Performance Remote Terminal
by GE Medical Systems Information Technologies
510(k) K904358
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904358 | Date5 Oct 1990 | 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- Withdrawn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 Model 855 Enhanced Performance Remote Terminal is a System, Monitoring, Perinatal device designed for remote monitoring in obstetrics and gynecology. It facilitates the transmission of fetal and maternal monitoring data from bedside terminals to central stations, enabling real-time assessment of high-risk pregnancies and labor progress. This device supports continuous monitoring of fetal heart rate, uterine contractions, and maternal vital signs, aiding clinical decision-making in perinatal care settings.
This terminal is supplied as a reusable medical device and is intended for use in clinical environments where obstetric and gynecologic monitoring is required. It operates within the regulatory framework of FDA 510(k) clearance (K904358), adhering to 21 CFR 884.2740 for perinatal monitoring systems. The device is not classified as MRI-safe or MRI-conditional, and its performance is optimized for integration with central monitoring systems in labor and delivery units. Maintenance and calibration follow manufacturer guidelines to ensure accurate and reliable data transmission.
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Questions
AI-generated answers, 1 Oct 2026
What is the Model 855 Enhanced Performance Remote Terminal used for?
The Model 855 Enhanced Performance Remote Terminal is designed for remote monitoring in obstetrics and gynecology. It transmits fetal heart rate, uterine contractions, and maternal vital signs from bedside terminals to central stations, enabling real-time assessment of high-risk pregnancies and labor progress. This facilitates clinical decision-making in perinatal care settings.
Is the Model 855 Remote Terminal reusable or single-use?
The Model 855 Enhanced Performance Remote Terminal is a reusable medical device. It is intended for use in clinical environments where obstetric and gynecologic monitoring is required, and it must be maintained and calibrated according to manufacturer guidelines to ensure accurate and reliable data transmission.
What regulatory framework does the Model 855 Remote Terminal follow?
The Model 855 Enhanced Performance Remote Terminal operates under FDA 510(k) clearance (K904358) and adheres to the regulatory requirements outlined in 21 CFR 884.2740 for perinatal monitoring systems. This clearance ensures it meets the necessary safety and performance standards for use in obstetric and gynecologic settings.
Can the Model 855 Remote Terminal be used with MRI equipment?
No, the Model 855 Enhanced Performance Remote Terminal is not classified as MRI-safe or MRI-conditional. Its design and performance are optimized for integration with central monitoring systems in labor and delivery units, not for use in MRI environments.
What types of data does the Model 855 Remote Terminal monitor?
The Model 855 Enhanced Performance Remote Terminal continuously monitors fetal heart rate, uterine contractions, and maternal vital signs. This comprehensive data transmission aids clinicians in assessing the progress of labor and the health of both mother and fetus in real-time.