Advanced Bioelectric Corporation
CanadaFDA applicant, unverified
- Devices
- 1
What Advanced Bioelectric Corporation makes
Advanced Bioelectric Corporation manufactures the ACCUHEART ELECTRODE BELT, a wearable device designed for continuous electrocardiogram (ECG) monitoring to detect and record heart rhythms.
The ACCUHEART ELECTRODE BELT is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Accuheart Electrode Belt Ref K043361
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Advanced Bioelectric Corporation have in the registry?
The registry currently lists 1 device for Advanced Bioelectric Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Bioelectric Corporation's devices?
Among its 1 most recently registered device, Advanced Bioelectric Corporation has devices listed in FDA 510(k) (1 device).
What risk classes do Advanced Bioelectric Corporation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Advanced Bioelectric Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Bioelectric Corporation in the registry?
The most recently registered devices listed for Advanced Bioelectric Corporation include ACCUHEART ELECTRODE BELT.