Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K030812 FDA 510(k)
- FDA Product Code
- MHX 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 Datex-Ohmeda S/5 Anesthesia Monitor is a physiological patient monitor designed for real-time assessment of hemodynamic, respiratory, ventilatory, gastrointestinal/regional perfusion, and neurophysiological parameters. It incorporates advanced features such as arrhythmia detection, ST-segment analysis, Bispectral Index (BIS), and Entropy monitoring (State Entropy and Response Entropy) to support comprehensive patient monitoring during anesthesia and critical care procedures.
This device is intended for use in hospital settings and is supplied with L-AN03 and L-ANE03A software. It is classified as a Class II medical device under FDA regulations (510(k) clearance) and is intended for single-use or reusable applications depending on manufacturer guidelines. The monitor is equipped with multiple screens, a dedicated alarm system, and advanced reporting options. No specific MRI safety information or sterility details are provided in the available data.
Frequently asked questions
What types of physiological parameters does the Datex-Ohmeda S/5 Anesthesia Monitor track in real-time during anesthesia and critical care procedures?
The Datex-Ohmeda S/5 Anesthesia Monitor tracks a wide range of physiological parameters, including hemodynamic, respiratory, ventilatory, gastrointestinal/regional perfusion, and neurophysiological metrics. It also features advanced monitoring capabilities such as arrhythmia detection, ST-segment analysis, Bispectral Index (BIS), and Entropy monitoring (State Entropy and Response Entropy) to provide comprehensive patient assessment during anesthesia and critical care.
Is the Datex-Ohmeda S/5 Anesthesia Monitor intended for single-use or reusable applications, and how should it be handled?
The Datex-Ohmeda S/5 Anesthesia Monitor is designed for either single-use or reusable applications, depending on the manufacturer’s guidelines. Since no specific sterility details are provided, it is critical to follow the manufacturer’s instructions for cleaning, disinfection, and reprocessing if intended for reuse. Always verify the appropriate handling procedures to ensure patient safety and device functionality.
What software versions come included with the Datex-Ohmeda S/5 Anesthesia Monitor, and how might they impact its functionality?
The Datex-Ohmeda S/5 Anesthesia Monitor is supplied with L-AN03 and L-ANE03A software versions. These software versions likely enhance its capabilities, such as advanced monitoring features (e.g., BIS and Entropy), alarm systems, and reporting options. The specific functionalities may vary slightly depending on the software version, so users should refer to the manufacturer’s documentation for detailed compatibility and usage instructions.
What regulatory pathway was followed for the FDA clearance of the Datex-Ohmeda S/5 Anesthesia Monitor, and what does this mean for its use in clinical settings?
The Datex-Ohmeda S/5 Anesthesia Monitor received FDA clearance via a 510(k) submission, classified as a Class II medical device under FDA regulations. This means the device was determined to be substantially equivalent to a legally marketed predicate device and meets FDA safety and performance requirements. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should always follow the manufacturer’s instructions and institutional protocols for safe and effective use.
Does the Datex-Ohmeda S/5 Anesthesia Monitor include any specialized display or alarm features that could improve patient monitoring during anesthesia?
Yes, the Datex-Ohmeda S/5 Anesthesia Monitor is equipped with multiple screens for comprehensive parameter visualization and a dedicated alarm system to alert clinicians to critical changes in patient status. These features are designed to enhance real-time monitoring of hemodynamic, respiratory, and neurophysiological data, improving safety and responsiveness during anesthesia and critical care procedures.
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: Datex-ohmeda S/5 Anesthesia Monitor With L-an03 and L-ane03a Software, GE Datex Ohmeda S/5 Anesthesia Monitor - Soma Tech Intl, GE Datex-Ohmeda S/5 Series Technical Reference Manual, GE Datex-Ohmeda S/5 Series Technical Reference Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030812 | Class II | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- FDA Applicant
- Datex-Ohmeda
Sources (1)
- FDA 510(k) K030812 24 fields · synced Oct 6, 2026