Aerocrine AB
Country not established
- Devices
- 6
What Aerocrine AB makes
Aerocrine AB manufactures portable devices designed to measure airway inflammation using fractional exhaled nitric oxide (FeNO) testing. Their products include handheld monitors like the NIOX VERO and NIOX MINO, which assess lung inflammation in clinical and home settings. The NIOX ARTICLE and associated panels are accessories for these monitors, enabling specific diagnostic measurements.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance pathway. The company’s products are listed in the FDA’s 510(k) registry. Aerocrine AB operates with a presence in the United States.
Catalogue
NIOX VERO Airway Inflammation Monitor Ref K150233
Regimes: 510(k) Registry: 510(k)Niox Article No: 02-1000 Ref DEN030001
Regimes: De Novo Registry: 510(k)Niox Vero Airway Inflammation Monitor Ref K133898
Regimes: 510(k) Registry: 510(k)Niox Mino Ref K072816
Regimes: 510(k) Registry: 510(k)Niox Mino Model 09-1000 Ref K101034
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aerocrine AB have in the registry?
The registry currently lists 6 devices for Aerocrine AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aerocrine AB's devices?
Among its 6 most recently registered devices, Aerocrine AB has devices listed in FDA 510(k) (6 devices).
What risk classes do Aerocrine AB's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Aerocrine AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aerocrine AB in the registry?
The most recently registered devices listed for Aerocrine AB include NIOX VERO Airway Inflammation Monitor, NIOX ARTICLE NO: 02-1000, NIOX MINO and NIOX MINO MODEL 09-1000.