Cardio Control BV
Country not established
- Devices
- 4
What Cardio Control BV makes
Cardio Control BV manufactures electrocardiogram (ECG) devices, including portable and standalone systems like the Cardio Perfect Portable, Cardio Perfect MD, and Cardio Perfect ST 2001. These products are designed for cardiac monitoring, featuring both hardware and associated software (e.g., Cardio Perfect versions 4.0 and above for DOS). The systems support ECG recording, analysis, and diagnostic interpretation for clinical use.
The company’s devices fall under FDA Class II regulatory classification and are listed via 510(k) premarket notifications. The portfolio is authorised for commercial distribution in the US, where the manufacturer is based. No additional registries or international authorisations are referenced.
Catalogue
Cardio Perfect, Cardio Perfect Md Ref K913374
Regimes: 510(k) Registry: 510(k)Cardio Perfect, Cardio Perfect Md Ref K922898
Regimes: 510(k) Registry: 510(k)Cardio Perfect St 2001 Ref K935732
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardio Control BV have in the registry?
The registry currently lists 4 devices for Cardio Control BV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio Control BV's devices?
Among its 4 most recently registered devices, Cardio Control BV has devices listed in FDA 510(k) (4 devices).
What risk classes do Cardio Control BV's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Cardio Control BV's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardio Control BV in the registry?
The most recently registered devices listed for Cardio Control BV include CARDIO PERFECT, CARDIO PERFECT MD, CARDIO PERFECT ST 2001 and HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT.