Schwarzer Cardiotek GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Schwarzer Cardiotek GmbH makes
Schwarzer Cardiotek GmbH manufactures the EP-TRACER System, a device designed for electrophysiological mapping and catheter ablation procedures in cardiac electrophysiology.
The EP-TRACER System is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
EP-TRACER System Ref K183266
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Schwarzer Cardiotek GmbH have in the registry?
The registry currently lists 1 device for Schwarzer Cardiotek GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Schwarzer Cardiotek GmbH's devices?
Among its 1 most recently registered device, Schwarzer Cardiotek GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Schwarzer Cardiotek GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Schwarzer Cardiotek GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Schwarzer Cardiotek GmbH in the registry?
The most recently registered devices listed for Schwarzer Cardiotek GmbH include EP-TRACER System.