Schwarzer GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Schwarzer GmbH makes
Schwarzer GmbH manufactures the CARDIS, a medical device designed for cardiac monitoring and analysis, likely used in clinical or diagnostic settings to assess heart function and rhythm.
The CARDIS device is classified as Class II under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Cardis Ref K023015
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Schwarzer GmbH have in the registry?
The registry currently lists 1 device for Schwarzer GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Schwarzer GmbH's devices?
Among its 1 most recently registered device, Schwarzer GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Schwarzer GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Schwarzer GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Schwarzer GmbH in the registry?
The most recently registered devices listed for Schwarzer GmbH include CARDIS.