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Ge Datex-Ohmeda Aisys

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090233

by Datex-Ohmeda Inc.

Identifiers

510(k) Number
K090233 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 is a Gas-Machine, Anesthesia designed for the precise delivery of anesthetic gases and vapors during surgical procedures. It integrates ventilation, respiratory monitoring, and breathing system functionality to support controlled anesthesia administration in clinical settings. The device ensures accurate gas flow, oxygen concentration, and vapor delivery while providing real-time patient monitoring parameters.

Used primarily in operating rooms and anesthesia care units, the AISYS is a reusable, non-sterile medical device intended for professional healthcare settings. It operates under FDA 510(k) clearance (K090233) and adheres to regulatory standards for Class II devices (868.5160). The system includes modular components for scalability, with large-panel displays mounted on a rotatable arm for operator flexibility. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and compliance with medical device regulations.

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 Datex-Ohmeda Aisys Carestation Reference Manual, PDF GE Datex-Ohmeda Aisys - Technical Reference Manual.pdf, PDF GE Datex-Ohmeda Aisys - Soma Tech Intl, PDF GE Datex-Ohmeda Aisys - User Reference Manual.pdf - iFixit

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

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

Sources (1)

  • FDA 510(k) K090233 24 fields · synced Oct 1, 2026