Identifiers
- 510(k) Number
- K120726 FDA 510(k)
- FDA Product Code
- CBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Flight 60 Ventilator is a continuous, facility-use ventilator, classified as a medical device under the regulation number 868.5895. It is designed for use in anesthesiology. The device is substantially equivalent and has been cleared by the FDA.
The Flight 60 Ventilator is supplied with an operator's manual, which outlines the proper use and setup of the device. The ventilator is intended for facility use, and the operator is responsible for selecting the appropriate level and method of patient monitoring. The device has a product code of CBK and is registered under various registration numbers, including 1218058 and 3010017366.
Frequently asked questions
What is the Flight 60 Ventilator used for?
The Flight 60 Ventilator is designed for use in anesthesiology, providing continuous ventilation in a facility setting.
Is the Flight 60 Ventilator supplied with any additional materials?
Yes, the ventilator is supplied with an operator's manual, which outlines proper use and setup.
What type of clearance does the Flight 60 Ventilator have?
The Flight 60 Ventilator has been cleared by the FDA as substantially equivalent, with a product code of CBK and regulation number 868.5895.
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: Flight 60 - FlightMedical, Flight Medical Innovations Flight 60 Ventilator Manuals, Flight Medical Innovations Flight 60 Ventilator Operator's Manual, Flight Medical Innovations Flight 60 Ventilator Operator's Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120726 | Class II | Active |
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Manufacturer
- Manufacturer
- Flight Medical Innovations Ltd
- FDA Applicant
- Flight Medical Innovations , Ltd.
Sources (1)
- FDA 510(k) K120726 24 fields · synced Sep 25, 2026