Inofab Saglik Teknolojileri A.S
TürkiyeFDA applicant, unverified
- Devices
- 1
What Inofab Saglik Teknolojileri A.S makes
Inofab Saglik Teknolojileri A.S manufactures spirometry devices, including the SpiroHome Personal for home use and the SpiroHome Clinic for clinical settings. These devices measure lung function parameters such as forced expiratory volume and peak flow rate, aiding in the diagnosis and monitoring of respiratory conditions.
The company’s spirometry devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is regulated in the United States, where the manufacturer is based.
Catalogue
SpiroHome Personal, SpiroHome Clinic Ref K213754
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Inofab Saglik Teknolojileri A.S have in the registry?
The registry currently lists 1 device for Inofab Saglik Teknolojileri A.S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Inofab Saglik Teknolojileri A.S's devices?
Among its 1 most recently registered device, Inofab Saglik Teknolojileri A.S has devices listed in FDA 510(k) (1 device).
What risk classes do Inofab Saglik Teknolojileri A.S's devices fall under?
Among its 1 most recently registered device, the classes recorded for Inofab Saglik Teknolojileri A.S's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Inofab Saglik Teknolojileri A.S in the registry?
The most recently registered devices listed for Inofab Saglik Teknolojileri A.S include SpiroHome Personal, SpiroHome Clinic.