Spirotech, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Spirotech, Inc. makes
Spirotech, Inc. manufactures spirometers, including the ST-5500, ST-550, and 300 models, designed for measuring lung function and airflow in clinical and home settings. These devices are used to assess respiratory conditions by quantifying parameters such as forced expiratory volume and peak flow rates.
The company’s spirometers are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance process. These products are intended for use in the United States and comply with applicable FDA requirements for diagnostic respiratory devices.
Catalogue
Spirotech St-5500 Ref K823770
Regimes: 510(k) Registry: 510(k)Spirotech 300 Ref K823771
Regimes: 510(k) Registry: 510(k)Spirotech St-550 Ref K840972
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spirotech, Inc. have in the registry?
The registry currently lists 3 devices for Spirotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spirotech, Inc.'s devices?
Among its 3 most recently registered devices, Spirotech, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Spirotech, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Spirotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spirotech, Inc. in the registry?
The most recently registered devices listed for Spirotech, Inc. include SPIROTECH ST-5500, SPIROTECH 300 and SPIROTECH ST-550.