Datex Medical Instrumentation, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Datex Medical Instrumentation, Inc. makes
The company produces patient monitoring and critical care devices, including capnography systems like the CARDIOCAP II™ for respiratory monitoring, and modular monitoring platforms such as the AS/3 series. These include airway management modules (AS/3 COMPACT AIRWAY MODULE M-CAIOV), cardiac output and mixed venous oxygen saturation monitors (AS/3 CARDIAC OUTPUT & SVO₂ MODULE), and network connectivity solutions (AS/3 NETWORK LINK). Additional modules support non-invasive monitoring (AS/3 NMT MODULE).
These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance. The company is based in the United States.
Catalogue
Cardiocap Ii(Tm) Ref K912530
Regimes: 510(k) Registry: 510(k)As/3 Network Link Ref K953006
Regimes: 510(k) Registry: 510(k)As/3 Compact Airway Module M-Caiov Ref K960490
Regimes: 510(k) Registry: 510(k)As/3 Cardiac Output & SVO2 Module Ref K961063
Regimes: 510(k) Registry: 510(k)As/3 Nmt Module Ref K955026
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Datex Medical Instrumentation, Inc. have in the registry?
The registry currently lists 5 devices for Datex Medical Instrumentation, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Datex Medical Instrumentation, Inc.'s devices?
Among its 5 most recently registered devices, Datex Medical Instrumentation, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Datex Medical Instrumentation, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Datex Medical Instrumentation, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Datex Medical Instrumentation, Inc. in the registry?
The most recently registered devices listed for Datex Medical Instrumentation, Inc. include CARDIOCAP II(TM), AS/3 NETWORK LINK, AS/3 COMPACT AIRWAY MODULE M-CAIOV and AS/3 CARDIAC OUTPUT & SVO2 MODULE.