Columbus Instruments Intl. Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Columbus Instruments Intl. Corp. makes
Columbus Instruments International Corp. manufactures physiological monitoring and research devices, including systems for measuring oxygen consumption (ISO-THERMEX, OXYMAX), body temperature regulation (CARDIOTHERM-500X), and cardiac function (CARDIOMAX-II). The company also produces equipment for assessing tremor activity (TREMOR MONITOR), designed for clinical and laboratory use.
These devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. The company operates from the United States.
Catalogue
Iso-Thermex Ref K861100
Regimes: 510(k) Registry: 510(k)Tremor Monitor Ref K782036
Regimes: 510(k) Registry: 510(k)Oxymax Ref K895791
Regimes: 510(k) Registry: 510(k)Cardiomax-Ii Ref K861543
Regimes: 510(k) Registry: 510(k)Cardiotherm-500X Ref K771718
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Columbus Instruments Intl. Corp. have in the registry?
The registry currently lists 5 devices for Columbus Instruments Intl. Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Columbus Instruments Intl. Corp.'s devices?
Among its 5 most recently registered devices, Columbus Instruments Intl. Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Columbus Instruments Intl. Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Columbus Instruments Intl. Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Columbus Instruments Intl. Corp. in the registry?
The most recently registered devices listed for Columbus Instruments Intl. Corp. include ISO-THERMEX, TREMOR MONITOR, OXYMAX and CARDIOMAX-II.