Cincinnati Sub-Zero
Country not established
- Devices
- 2
What Cincinnati Sub-Zero makes
Cincinnati Sub-Zero manufactures medical-grade hypothermia therapy devices, including the HEMOTHERM Model 400 and MAXITHERM systems. These products are designed to regulate patient temperature during and after procedures requiring controlled hypothermia, such as cardiac surgery or neuroprotection.
The company’s portfolio is classified under FDA Class II devices and is authorised through 510(k) clearances. The devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Hemotherm Model 400 Ref K811742
Regimes: 510(k) Registry: 510(k)Maxitherm Ref K811743
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cincinnati Sub-Zero have in the registry?
The registry currently lists 2 devices for Cincinnati Sub-Zero. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cincinnati Sub-Zero's devices?
Among its 2 most recently registered devices, Cincinnati Sub-Zero has devices listed in FDA 510(k) (2 devices).
What risk classes do Cincinnati Sub-Zero's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cincinnati Sub-Zero's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cincinnati Sub-Zero in the registry?
The most recently registered devices listed for Cincinnati Sub-Zero include HEMOTHERM MODEL 400 and MAXITHERM.