Eclipse
by Diagnostic Medical Instruments 510(k)
Active
510(k) K830407
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830407 | Date24 Mar 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- DSI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Eclipse is a Detector and Alarm for arrhythmia, designed to monitor and alert clinicians to abnormal heart rhythms. Classified as a Class II device under FDA regulations, it operates within the cardiovascular specialty, providing real-time detection of arrhythmic events. Its primary function is to identify irregular heartbeats and trigger audible or visual alarms to facilitate timely medical intervention.
This device is intended for use in clinical settings, where it is connected to cardiac monitoring systems to detect arrhythmias. Supplied as a reusable medical instrument, it requires proper calibration and maintenance as specified by the manufacturer. The Eclipse adheres to FDA clearance under 510K (K830407), with regulatory compliance ensured through traditional review processes. No specific sterility or MRI safety information is provided in the data.
Other devices from Diagnostic Medical Instruments
Questions
AI-generated answers, 1 Oct 2026
What is the Eclipse arrhythmia detector and alarm used for?
The Eclipse is designed to monitor patients for arrhythmias—abnormal heart rhythms—in clinical environments. It connects to cardiac monitoring systems and triggers alarms (audible or visual) when irregular heartbeats are detected, enabling timely clinical intervention. This helps clinicians respond promptly to potential cardiac events.
Is the Eclipse a single-use or reusable device?
The Eclipse is supplied as a reusable medical instrument. Like other reusable devices, it requires proper calibration, maintenance, and cleaning as specified by the manufacturer to ensure reliable performance and infection control. Regular servicing is essential to maintain accuracy and functionality over repeated use.
What regulatory approval does the Eclipse hold?
The Eclipse holds FDA clearance under the 510K pathway (K830407), classified as a Class II device. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness in detecting arrhythmias. No additional regulatory status (e.g., CE marking) is mentioned in the provided data.
How is the Eclipse connected to cardiac monitoring systems?
The Eclipse is intended for integration with existing cardiac monitoring systems in clinical settings. While the exact connection method isn’t detailed, its design implies compatibility with standard ECG or cardiac monitoring infrastructure. Clinicians should follow manufacturer guidelines for proper setup, calibration, and troubleshooting to ensure accurate arrhythmia detection.
Does the Eclipse require sterilization, and if so, how?
The provided data does not specify any sterility requirements or recommended sterilization methods for the Eclipse. As a reusable device, it should be cleaned and disinfected according to standard medical device reprocessing protocols to prevent contamination between uses. Always refer to the manufacturer’s instructions for reprocessing to ensure compliance with infection control standards.