Datex-Ohmeda S/5 Device Interfacing Solution N-DISXXXX..01 with N-DISVENT..02
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070421 FDA 510(k)
- FDA Product Code
- MSX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Datex-Ohmeda S/5 Device Interfacing Solution is a System, Network and Communication, Physiological Monitors device designed to facilitate data transfer between external medical devices and monitoring systems. It enables seamless integration of physiological signals, ensuring accurate and synchronized communication between connected equipment in clinical settings.
This solution is supplied as a reusable interface component, intended for use in hospital or critical care environments where multiple monitoring systems require interoperability. It has received FDA 510(k) clearance under classification MSX and regulation 870.2300, with a decision date of 2007-03-13. The device operates within standard medical infrastructure without MRI-specific constraints and is not classified as single-use.
Frequently asked questions
What clinical environments is the Datex-Ohmeda S/5 Device Interfacing Solution designed for, and how does it improve workflow?
The Datex-Ohmeda S/5 Device Interfacing Solution is specifically designed for hospital and critical care environments where multiple monitoring systems require seamless integration. It facilitates data transfer between external medical devices and monitoring systems, ensuring accurate and synchronized communication of physiological signals. This reduces manual data entry errors and enhances workflow efficiency by enabling real-time interoperability between connected equipment.
Is this device reusable or single-use, and what does that mean for maintenance and cost?
The Datex-Ohmeda S/5 Device Interfacing Solution is a reusable interface component, meaning it is intended for repeated use within clinical settings. This design choice supports cost efficiency by eliminating the need for single-use replacements, though it does require proper cleaning, disinfection, and maintenance protocols to ensure reliability and hygiene between uses.
Can this device be used with MRI equipment, or are there any special compatibility considerations?
The Datex-Ohmeda S/5 Device Interfacing Solution is not classified as MRI-specific, meaning it is designed to operate within standard medical infrastructure without additional MRI-related constraints. However, as with any interfacing device, compatibility should be verified with the specific MRI system and manufacturer guidelines to ensure safe and accurate data transmission in MRI environments.
What regulatory pathway was followed for FDA clearance, and how does that affect its use in clinical settings?
The device received FDA 510(k) clearance under classification MSX and regulation 870.2300, with a decision date of March 13, 2007. This clearance was granted as substantially equivalent to a predicate device, ensuring it meets FDA safety and performance standards for use in clinical settings. The Cardiovascular (CV) advisory committee reviewed it, but this does not imply a clinical indication—it simply reflects the submission’s filing category.
How does this solution ensure accurate synchronization of physiological signals across different monitoring systems?
The Datex-Ohmeda S/5 Device Interfacing Solution is engineered to enable seamless integration between external medical devices and monitoring systems, ensuring that physiological signals are transmitted accurately and in real time. This synchronization eliminates discrepancies that can arise from manual data entry or asynchronous communication, which is critical in high-stakes environments like critical care where timely and reliable monitoring is essential.
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 Device Interfacing Solution, N-disxxxx..01 With N ..., PDF DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION… - FDA.report, DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION by GE HEALTHCARE | FDA 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070421 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K070421 24 fields · synced Oct 6, 2026