Emcools Emergency Medical Cooling Systems AG
AustriaFDA applicant, unverified
- Devices
- 1
What Emcools Emergency Medical Cooling Systems AG makes
The company manufactures the EMCOOLSPAD, a portable emergency cooling system designed for rapid therapeutic hypothermia in pre-hospital and emergency care settings to reduce brain injury risk after cardiac arrest.
The EMCOOLSPAD is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Emcoolspad Ref K100071
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Emcools Emergency Medical Cooling Systems AG have in the registry?
The registry currently lists 1 device for Emcools Emergency Medical Cooling Systems AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Emcools Emergency Medical Cooling Systems AG's devices?
Among its 1 most recently registered device, Emcools Emergency Medical Cooling Systems AG has devices listed in FDA 510(k) (1 device).
What risk classes do Emcools Emergency Medical Cooling Systems AG's devices fall under?
Among its 1 most recently registered device, the classes recorded for Emcools Emergency Medical Cooling Systems AG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Emcools Emergency Medical Cooling Systems AG in the registry?
The most recently registered devices listed for Emcools Emergency Medical Cooling Systems AG include EMCOOLSPAD.