Infinity Multiview Telemetry System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K033305 FDA 510(k)
- FDA Product Code
- DSI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Infinity Multiview Telemetry System is a Detector and Alarm for Arrhythmia, designed to monitor and transmit physiological data from multiple patients. It functions as a central monitoring device, enabling real-time visualization and audible alerts for critical cardiac events, such as arrhythmias, across a networked clinical environment.
This system is intended for use in acute care settings, integrating with Draeger patient monitoring solutions to provide remote display and telemetry capabilities. Supplied as a reusable, non-sterile device, it operates within standard clinical environments without MRI compatibility constraints. Authorized under FDA 510(k) clearance (K033305), it adheres to regulatory standards for cardiovascular monitoring and is classified as a Class II device under 870.1025.
Frequently asked questions
What is the Infinity Multiview Telemetry System used for?
The Infinity Multiview Telemetry System is designed as a detector and alarm for arrhythmia, enabling continuous monitoring and transmission of physiological data from multiple patients in acute care settings. It provides real-time visualization and audible alerts for critical cardiac events, such as arrhythmias, across a networked clinical environment. This system integrates with Draeger patient monitoring solutions to offer remote display and telemetry capabilities, improving clinical oversight in busy wards or ICUs.
How is the Infinity Multiview Telemetry System supplied and what are its sterility and reuse details?
The Infinity Multiview Telemetry System is supplied as a reusable, non-sterile device. Since it is intended for central monitoring and networked use in clinical environments, it is not required to be sterile. Reusability aligns with its design for long-term deployment in acute care settings, where durability and consistent performance are prioritized over single-use convenience.
Is the Infinity Multiview Telemetry System compatible with MRI environments?
No, the Infinity Multiview Telemetry System is not MRI-compatible. Its specifications and intended use are limited to standard clinical environments without MRI constraints. Clinicians should ensure the device is used in areas where MRI procedures are not performed to avoid interference or safety risks.
What regulatory pathway does the Infinity Multiview Telemetry System follow?
The Infinity Multiview Telemetry System is authorized under FDA 510(k) clearance (K033305) and classified as a Class II device under the regulatory category 870.1025. This pathway confirms its substantial equivalence to a predicate device and adherence to cardiovascular monitoring standards, ensuring its safety and effectiveness for detecting and alerting on arrhythmias in acute care settings.
What types of physiological data can the Infinity Multiview Telemetry System monitor?
While the provided data does not specify exact physiological parameters, the Infinity Multiview Telemetry System is explicitly designed as a detector and alarm for arrhythmia. This implies it monitors cardiac rhythms and transmits alerts for abnormal heart rhythms, such as tachycardia, bradycardia, or fibrillation, across multiple patients in real time. Integration with Draeger’s patient monitoring solutions likely extends its capabilities to include other vital signs, but arrhythmia detection remains its primary focus.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Infinity® Acute Care System | Draeger, INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM (K060223) — FDA 510 (k ..., Dräger Infinity CentralStation, Infinity Telemetry System, Infinity ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033305 | Class II | Active |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA 510(k) K033305 24 fields · synced Oct 6, 2026