Spirometrics Medical Equipment Co.
Country not established
- Devices
- 3
What Spirometrics Medical Equipment Co. makes
Spirometrics Medical Equipment Co. manufactures spirometry devices, including portable and wireless models like the PC FLOW + and FLOWMATE II PLUS (Model #4000), as well as the FLOWMATE LTE. These devices measure lung function parameters such as forced expiratory volume and peak flow rates, primarily for respiratory diagnostics and patient monitoring.
The company’s spirometry devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in clinical and home settings to assess pulmonary function. The manufacturer is based in the United States.
Catalogue
Pc Flow + Ref K001528
Regimes: 510(k) Registry: 510(k)Flowmate Ii Plus, Model #4000 Ref K982956
Regimes: 510(k) Registry: 510(k)Flowmate Lte Ref K954759
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spirometrics Medical Equipment Co. have in the registry?
The registry currently lists 3 devices for Spirometrics Medical Equipment Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spirometrics Medical Equipment Co.'s devices?
Among its 3 most recently registered devices, Spirometrics Medical Equipment Co. has devices listed in FDA 510(k) (3 devices).
What risk classes do Spirometrics Medical Equipment Co.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Spirometrics Medical Equipment Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spirometrics Medical Equipment Co. in the registry?
The most recently registered devices listed for Spirometrics Medical Equipment Co. include PC FLOW +, FLOWMATE II PLUS, MODEL #4000 and FLOWMATE LTE.