Skyfine Inc. Limited
TaiwanFDA applicant, unverified
- Devices
- 1
What Skyfine Inc. Limited makes
Skyfine Inc. Limited manufactures breathalyzer devices, including models AT576, AT577, AT578, and AT579, designed for measuring alcohol concentration in exhaled breath.
These devices are classified as Class I under regulatory frameworks and have been submitted for 510(k) clearance with the FDA. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Skyfine Inc. Limited have in the registry?
The registry currently lists 1 device for Skyfine Inc. Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Skyfine Inc. Limited's devices?
Among its 1 most recently registered device, Skyfine Inc. Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Skyfine Inc. Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Skyfine Inc. Limited's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Skyfine Inc. Limited in the registry?
The most recently registered devices listed for Skyfine Inc. Limited include ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579.