Aquarius Medical Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Aquarius Medical Corp. makes
Aquarius Medical Corp. manufactures medical devices for temperature management, including the AQUACENTER 2000 SYSTEM—a controlled cooling system—and the THERMO-STAT SYSTEM, designed for therapeutic hypothermia applications. The ACROTHERM device is also part of their portfolio, likely used for localized temperature regulation in clinical settings.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Aquacenter 2000 System Ref K954964
Regimes: 510(k) Registry: 510(k)Thermo-Stat System Ref K970367
Regimes: 510(k) Registry: 510(k)Acrotherm Ref K003368
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aquarius Medical Corp. have in the registry?
The registry currently lists 3 devices for Aquarius Medical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aquarius Medical Corp.'s devices?
Among its 3 most recently registered devices, Aquarius Medical Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Aquarius Medical Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Aquarius Medical Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aquarius Medical Corp. in the registry?
The most recently registered devices listed for Aquarius Medical Corp. include AQUACENTER 2000 SYSTEM, THERMO-STAT SYSTEM and ACROTHERM.