Primary Technology, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Primary Technology, LLC makes
Primary Technology, LLC manufactures the SPECTRAPULSE, a device designed for pulse oximetry and photoplethysmography monitoring, enabling non-invasive measurement of blood oxygen saturation and heart rate.
The SPECTRAPULSE is classified as a Class II medical device in the US and is listed under FDA’s 510(k) premarket notification process. The company is based in the United States.
Catalogue
Spectrapulse Ref K031680
Regimes: 510(k) Registry: 510(k)Spectrapulse Ref K022607
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Primary Technology, LLC have in the registry?
The registry currently lists 2 devices for Primary Technology, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Primary Technology, LLC's devices?
Among its 2 most recently registered devices, Primary Technology, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Primary Technology, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Primary Technology, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Primary Technology, LLC in the registry?
The most recently registered devices listed for Primary Technology, LLC include SPECTRAPULSE.