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Ge Datex-Ohmeda Aisys Cs2 (aisys Cs^2)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K132530

by Datex-Ohmeda Inc.

Identifiers

510(k) Number
K132530 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 AISYS CS² is a Gas-Machine, Anesthesia (OpenFDA classification: 868.5160), designed for the delivery of anesthetic gases and vapors during surgical procedures. It integrates ventilation, respiratory monitoring, and breathing system functionality to support patient management in anesthesia care settings.

This device is supplied as a reusable, modular system with configurable components, including vaporizers for sevoflurane, isoflurane, and desflurane, as well as integrated monitoring capabilities. It operates in clinical environments requiring precise gas delivery and is regulated under FDA 510K and MDD compliance, with a Device Class II designation. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and safety.

Frequently asked questions

Is the GE Datex-Ohmeda AISYS CS² designed for single-use or can it be reused in clinical settings?

The GE Datex-Ohmeda AISYS CS² is explicitly described as a reusable, modular system. This means it is built for repeated use in clinical environments, provided it undergoes proper maintenance and cleaning as outlined by the manufacturer’s guidelines. Reusability is a key feature to support cost-effectiveness and sustainability in anesthesia care settings.

What types of anesthetic gases and vapors can be delivered using this device, and how does it integrate with patient monitoring?

The AISYS CS² is designed to deliver anesthetic gases and vapors, including sevoflurane, isoflurane, and desflurane, as part of its vaporizer system. Beyond gas delivery, it integrates ventilation and respiratory monitoring into a single platform, allowing clinicians to manage breathing systems and patient vitals simultaneously. This consolidation supports comprehensive patient care during surgical procedures.

How is the AISYS CS² configured, and what flexibility does it offer in clinical settings?

The device is a modular system, meaning it can be customized with interchangeable components like vaporizers and monitoring tools. This modularity allows clinical settings to adapt the system to specific workflows, patient needs, or procedural requirements. The flexibility ensures compatibility with various anesthesia protocols while maintaining precise gas delivery and monitoring capabilities.

What regulatory pathways does the AISYS CS² follow, and how does this affect its use in hospitals?

The AISYS CS² is regulated under FDA 510K clearance and MDD compliance, with a Class II designation. This means it has undergone rigorous review by the FDA’s Anesthesiology Advisory Committee (AN) to ensure safety and effectiveness. Hospitals can rely on its regulatory status as evidence of its suitability for use in anesthesia care, though adherence to manufacturer guidelines for storage and maintenance remains critical for continued performance.

Are there specific storage requirements for the AISYS CS² to maintain its functionality and safety?

While the provided data does not detail exact storage conditions, the device’s reusable and modular design implies that proper storage—such as in a clean, dry environment away from direct sunlight or extreme temperatures—is essential. The manufacturer’s guidelines (not specified here) would outline precise storage protocols to prevent contamination, damage, or degradation of components, ensuring reliable operation when needed in clinical settings.

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: GE auisys cs2 User's Reference Manual - ManualMachine.com, Datex Ohmeda Aisys CS2 Anesthesia Machine - MedGill Ltd, GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) (K132530) - Innolitics

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) K132530 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026