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GE Datex-Ohmeda Avance CS2

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K123125

by Datex-Ohmeda Inc.

Identifiers

510(k) Number
K123125 FDA 510(k)
FDA Product Code
BSZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5160 FDA 510(k)
Regulation Number
868.5160 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The GE Datex-Ohmeda Avance CS2 is a Gas-Machine, Anesthesia designed for the precise delivery and monitoring of anesthetic gases and vapors in clinical settings. It integrates multiple functions, including gas blending, vaporization, and patient monitoring, to support safe and controlled anesthesia administration during surgical procedures.

This device is intended for use in operating rooms and anesthesia care areas, supplied as a reusable medical instrument with FDA 510(k) clearance and compliance with the Medical Devices Directive (MDD). It operates within Class II regulatory classification and is intended for single-patient use per session, with maintenance and servicing conducted by authorized service centers. The device adheres to strict safety standards for anesthetic gas delivery and monitoring.

Frequently asked questions

What clinical setting is the GE Datex-Ohmeda Avance CS2 designed for, and how does it support anesthesia administration?

The GE Datex-Ohmeda Avance CS2 is specifically designed for use in operating rooms and anesthesia care areas. It integrates gas blending, vaporization, and patient monitoring into a single system, ensuring precise delivery of anesthetic gases and vapors while maintaining safety standards. This consolidation of functions helps clinicians administer anesthesia more effectively during surgical procedures.

Is the GE Datex-Ohmeda Avance CS2 intended for single-use or reusable applications, and what maintenance requirements apply?

The device is supplied as a reusable medical instrument, intended for single-patient use per session. After use, it must be serviced and maintained by authorized service centers to ensure proper functionality and safety. This design aligns with its regulatory classification as a Class II device, requiring adherence to strict maintenance protocols.

What regulatory pathways does the GE Datex-Ohmeda Avance CS2 follow, and how does this impact its use?

The device holds FDA 510(k) clearance, indicating it is deemed substantially equivalent to a predicate device, and complies with the Medical Devices Directive (MDD). This regulatory route ensures it meets safety and performance standards for anesthetic gas delivery and monitoring. The classification as a Class II device also means it undergoes additional scrutiny to validate its effectiveness and safety in clinical settings.

Are there multiple models or configurations of the GE Datex-Ohmeda Avance CS2, and how can I identify the correct one for my needs?

The device comes in multiple configurations, as indicated by the diverse registration numbers (e.g., 3013188547, 3005783425, etc.) and product code BSZ. These identifiers correspond to different models or variations, likely tailored for specific clinical workflows or anesthesia requirements. To ensure compatibility, verify the exact model number or registration number against your facility’s specifications or consult the manufacturer’s documentation.

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 AVANCE USER'S REFERENCE MANUAL Pdf Download, Datex-Ohmeda Avance Technical Reference Manual, PDF Avance - Frank's Hospital Workshop, Datex-ohmeda Avance Manuals | ManualsLib

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Datex-Ohmeda Inc.
FDA Applicant
Datex-Ohmeda, Inc.

Sources (2)

  • FDA 510(k) K123125 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026