Tristan Technologies, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Tristan Technologies, Inc. makes
Tristan Technologies, Inc. manufactures biomagnetometer systems, including standalone models like the 621/624 and the BabyMEG system designed for neonatal use, as well as the MagView system for clinical applications. These devices measure magnetic fields generated by neural activity to assess brain function.
The company’s biomagnetometer systems are classified as Class II devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Model 621/624 Biomagnetometer Ref K151135
510(k) 510(k)Babymeg Biomagnetometer System Ref K133419
510(k) 510(k)MagView BIOMAGNETOMETER SYSTEM Ref K152184
510(k) 510(k)
Frequently asked questions
How many devices does Tristan Technologies, Inc. have in the registry?
The registry currently lists 3 devices for Tristan Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tristan Technologies, Inc.'s devices?
Among its 3 most recently registered devices, Tristan Technologies, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Tristan Technologies, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Tristan Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tristan Technologies, Inc. in the registry?
The most recently registered devices listed for Tristan Technologies, Inc. include MODEL 621/624 BIOMAGNETOMETER, BABYMEG BIOMAGNETOMETER SYSTEM and MagView BIOMAGNETOMETER SYSTEM.