University of Michigan
Country not established
- Devices
- 2
What University of Michigan makes
The University of Michigan manufactures medical devices including the CT-compatible Fletcher System Applicator, designed for precise procedural applications in imaging-compatible settings, and the MR Extension Set (001), intended for use in magnetic resonance imaging environments.
These devices are classified under FDA categories Class I and Class II, with regulatory submissions supported through the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Ct-Compatible Fletcher System Applicator Ref K903403
Regimes: 510(k) Registry: 510(k)Mr Extension Set (001) Ref K964968
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does University of Michigan have in the registry?
The registry currently lists 2 devices for University of Michigan. Devices recorded under merged duplicate company entries are counted once.
Which registries list University of Michigan's devices?
Among its 2 most recently registered devices, University of Michigan has devices listed in FDA 510(k) (2 devices).
What risk classes do University of Michigan's devices fall under?
Among its 2 most recently registered devices, the classes recorded for University of Michigan's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from University of Michigan in the registry?
The most recently registered devices listed for University of Michigan include CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR and MR EXTENSION SET (001).