Thirona BV
NetherlandsFDA applicant, unverified FDA FEI 3014653800
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Thirona BV makes
Thirona BV manufactures spirometry devices, including the LungQ 4 and LungQ v3.0.0, designed for pulmonary function testing to measure lung capacity and airflow. These devices are intended for clinical and research use to assess respiratory health and diagnose conditions such as asthma or chronic obstructive pulmonary disease (COPPD).
The company’s spirometry devices fall under Class II regulatory classification in the US, requiring a 510(k) premarket notification submission to the FDA. These products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution. The company is based in the United States.
Catalogue
LungQ 4 Ref K250766
Regimes: 510(k) Registry: 510(k)LungQ Software Ref K173821
Regimes: 510(k) Registry: 510(k)LungQ v3.0.0 Ref K232412
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3014653800
- Address
- Toernooiveld 300, Nijmegen Gelderland
Frequently asked questions
How many devices does Thirona BV have in the registry?
The registry currently lists 3 devices for Thirona BV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Thirona BV's devices?
Among its 3 most recently registered devices, Thirona BV has devices listed in FDA 510(k) (3 devices).
What risk classes do Thirona BV's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Thirona BV's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Thirona BV in the registry?
The most recently registered devices listed for Thirona BV include LungQ 4, LungQ Software and LungQ v3.0.0.