Coltemp, Inc.
Country not established
- Devices
- 1
What Coltemp, Inc. makes
Coltemp, Inc. manufactures Class II medical devices, including the GUARDIAN and ANDINO models, which are designed for temperature monitoring and management applications.
These devices are regulated under the FDA’s 510(k) pathway as Class II products and are listed in the U.S. regulatory database. The company is based in the United States.
Catalogue
Guardian And Andino Models Ref K932991
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Coltemp, Inc. have in the registry?
The registry currently lists 1 device for Coltemp, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coltemp, Inc.'s devices?
Among its 1 most recently registered device, Coltemp, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Coltemp, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Coltemp, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Coltemp, Inc. in the registry?
The most recently registered devices listed for Coltemp, Inc. include GUARDIAN AND ANDINO MODELS.