Flow-I Anesthesia System C20, C30 & C40
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133958 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, and C40 is a Gas-Machine, Anesthesia designed for precise delivery of anesthetic gases and ventilation. It integrates advanced ventilation capabilities with low-flow anesthesia techniques to optimize patient safety and respiratory management during surgical procedures.
This system is intended for use in operating rooms and critical care settings, featuring models tailored for ergonomic adjustments and ceiling mounting. Supplied as a reusable medical device, it adheres to FDA 510(k) clearance and MDR compliance, with configurations supporting various patient care scenarios. The device operates within Class II regulatory classification under 21 CFR 868.5160 and includes multiple FEI and registration numbers for traceability.
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, Medicals International - Hospital Solutions - Maquet - Anesthesia, Maquet - Flow-i C20 Community, Manuals and Specifications | MedWrench
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K133958 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maquet Critical Care AB
Sources (2)
- FDA 510(k) K133958 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026