Roundworks Technologies Private Limited
IndiaFDA applicant, unverified
- Devices
- 1
What Roundworks Technologies Private Limited makes
Roundworks Technologies Private Limited manufactures the Alveoair Digital Spirometer, a device used for measuring lung function and airflow in clinical and home settings. It provides digital spirometry readings to assess respiratory health, including parameters like forced expiratory volume and peak flow.
The Alveoair Digital Spirometer is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Alveoair Digital Spirometer Ref K222525
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Roundworks Technologies Private Limited have in the registry?
The registry currently lists 1 device for Roundworks Technologies Private Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roundworks Technologies Private Limited's devices?
Among its 1 most recently registered device, Roundworks Technologies Private Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Roundworks Technologies Private Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Roundworks Technologies Private Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Roundworks Technologies Private Limited in the registry?
The most recently registered devices listed for Roundworks Technologies Private Limited include Alveoair Digital Spirometer.