Instrumentarium-Datex
Country not established
- Devices
- 2
What Instrumentarium-Datex makes
Instrumentarium-Datex manufactures medical devices for monitoring and analyzing respiratory gases, including a capnography recorder unit (NORMOCAP CR-102) and a carbon dioxide analyzer (NORMCAP CD-102). These devices are designed for use in clinical settings to measure and document exhaled carbon dioxide levels, supporting patient care and diagnostic procedures.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via 510(k) premarket notifications. These devices are intended for use in the United States, where compliance with FDA requirements is mandatory.
Catalogue
Normocap Cr-102, Recorder Unit Ref K802762
Regimes: 510(k) Registry: 510(k)Normcap Cd-102, Carbon Dioxide Analyzer Ref K801083
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Instrumentarium-Datex have in the registry?
The registry currently lists 2 devices for Instrumentarium-Datex. Devices recorded under merged duplicate company entries are counted once.
Which registries list Instrumentarium-Datex's devices?
Among its 2 most recently registered devices, Instrumentarium-Datex has devices listed in FDA 510(k) (2 devices).
What risk classes do Instrumentarium-Datex's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Instrumentarium-Datex's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Instrumentarium-Datex in the registry?
The most recently registered devices listed for Instrumentarium-Datex include NORMOCAP CR-102, RECORDER UNIT and NORMCAP CD-102, CARBON DIOXIDE ANALYZER.