Caldyne, Inc.
Country not established
- Devices
- 1
What Caldyne, Inc. makes
Caldyne, Inc. manufactures exhalometers, specifically the EX100 model, designed to measure exhaled breath parameters for diagnostic or monitoring purposes.
The company’s products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. Caldyne, Inc. is based in the United States.
Catalogue
Caldyne, Inc. Exhalometer EX100, Model EX100 Ref K051279
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Caldyne, Inc. have in the registry?
The registry currently lists 1 device for Caldyne, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Caldyne, Inc.'s devices?
Among its 1 most recently registered device, Caldyne, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Caldyne, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Caldyne, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Caldyne, Inc. in the registry?
The most recently registered devices listed for Caldyne, Inc. include CALDYNE, INC. EXHALOMETER EX100, MODEL EX100.