H&C Medical Devices Spa
ItalyFDA 510(k) applicant, unverified
- Devices
- 3
What H&C Medical Devices Spa makes
H&C Medical Devices Spa manufactures external defibrillators, including the AB Cardiettē Start 200 HV and the AB Cardiettē Daedalus View Base and AB Cardiettē Daedalus View HES, designed for automated or manual cardiac resuscitation. They also produce portable ECG devices for home monitoring and diagnostic use.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Ab Cardiette Start 200 Hv Ref K010822
510(k) 510(k)- 510(k) 510(k)
Ecg Home Ref K012012
510(k) 510(k)
Frequently asked questions
How many devices does H&C Medical Devices Spa have in the registry?
The registry currently lists 3 devices for H&C Medical Devices Spa. Devices recorded under merged duplicate company entries are counted once.
Which registries list H&C Medical Devices Spa's devices?
Among its 3 most recently registered devices, H&C Medical Devices Spa has devices listed in FDA 510(k) (3 devices).
What risk classes do H&C Medical Devices Spa's devices fall under?
Among its 3 most recently registered devices, the classes recorded for H&C Medical Devices Spa's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from H&C Medical Devices Spa in the registry?
The most recently registered devices listed for H&C Medical Devices Spa include AB CARDIETTE START 200 HV, AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES and ECG HOME.