Colorado Medtech, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Colorado Medtech, Inc. makes
Colorado Medtech, Inc. manufactures pulse oximetry modules, including the FIRST MEDIC PULSE OXIMETRY MODULE, which measures oxygen saturation in patients. They also produce respiratory support devices, such as the FRESH AIR system, designed for delivering controlled airflow to patients.
The company’s portfolio includes devices classified as Class II and Class III under FDA regulations, with products authorised through the 510(k) pathway. These devices are listed in the FDA’s regulatory database, and the manufacturer operates from the United States.
Catalogue
First Medic Pulse Oximetry Module Ref K955890
Regimes: 510(k) Registry: 510(k)Fresh Air Ref K981047
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Colorado Medtech, Inc. have in the registry?
The registry currently lists 2 devices for Colorado Medtech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Colorado Medtech, Inc.'s devices?
Among its 2 most recently registered devices, Colorado Medtech, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Colorado Medtech, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Colorado Medtech, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Colorado Medtech, Inc. in the registry?
The most recently registered devices listed for Colorado Medtech, Inc. include FIRST MEDIC PULSE OXIMETRY MODULE and FRESH AIR.