← Back to catalogue

Flow-i Anesthesia System C20, C30, C40

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K160665

by Maquet Critical Care AB

Identifiers

510(k) Number
K160665 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 Flow-i Anesthesia System C20, C30, C40 is a gas-machine, anesthesia device designed for the delivery of inhalation anesthesia. It operates as a semi-closed system, integrating ICU-grade ventilation technology with volume reflector technology and electronically controlled vaporizers for precise administration of anesthetics such as sevoflurane, desflurane, isoflurane, and nitrous oxide.

These systems are intended for use in operating rooms and hybrid OR environments, offering height-adjustable and ceiling-mounted configurations. Supplied as reusable medical devices, they comply with FDA 510(k) clearance and MDR requirements. The systems are classified as Class II devices under FDA regulations and are intended for professional healthcare settings, with no indication of MRI compatibility or single-use specifications.

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: Getinge Flow-i anesthesia machine - intelligent model, Flow-i Anesthesia Machine - Getinge, FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i ..., FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Maquet Critical Care AB

Sources (2)

  • FDA 510(k) K160665 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026