D. Swarovski & Co.
AustriaFDA 510(k) applicant, unverified
- Devices
- 1
What D. Swarovski & Co. makes
D. Swarovski & Co. manufactures ECG electrodes, specifically the Swaromed line, designed for use in electrocardiogram monitoring to detect and record the electrical activity of the heart.
The company’s ECG electrodes are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Ecg-Electrode(Swaromed) Ref K853939
510(k) 510(k)
Frequently asked questions
How many devices does D. Swarovski & Co. have in the registry?
The registry currently lists 1 device for D. Swarovski & Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list D. Swarovski & Co.'s devices?
Among its 1 most recently registered device, D. Swarovski & Co. has devices listed in FDA 510(k) (1 device).
What risk classes do D. Swarovski & Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for D. Swarovski & Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from D. Swarovski & Co. in the registry?
The most recently registered devices listed for D. Swarovski & Co. include ECG-ELECTRODE(SWAROMED).