Blue Focus
Country not established
- Devices
- 1
What Blue Focus makes
Blue Focus manufactures the AIO HD Otoscope, a handheld diagnostic device designed for visual examination of the ear canal and tympanic membrane. This otoscopic tool integrates high-definition imaging to enhance clinical assessment in medical settings.
The AIO HD Otoscope is classified as a Class I medical device under FDA regulations and is listed in the 510(k) clearance database. The company is based in the United States.
Catalogue
Aio Hd Otoscope Ref K123821
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Blue Focus have in the registry?
The registry currently lists 1 device for Blue Focus. Devices recorded under merged duplicate company entries are counted once.
Which registries list Blue Focus's devices?
Among its 1 most recently registered device, Blue Focus has devices listed in FDA 510(k) (1 device).
What risk classes do Blue Focus's devices fall under?
Among its 1 most recently registered device, the classes recorded for Blue Focus's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Blue Focus in the registry?
The most recently registered devices listed for Blue Focus include AIO HD OTOSCOPE.