Cardiodynamics International Corp.
United StatesFDA applicant, unverified
- Devices
- 11
What Cardiodynamics International Corp. makes
Cardiodynamics International Corp. manufactures hemodynamic monitoring systems, including portable and bedside devices that integrate 12-lead ECG capabilities with impedance plethysmography for real-time cardiovascular assessment. Their portfolio includes standalone monitors, sensor-cable assemblies, and software installation kits designed for clinical use in critical care and procedural settings. Examples include the BIOZ.COM System, BIOZ DX Hemodynamic Monitor, and variations of the BIOZ.PC Hemodynamic Monitor with proprietary sensors.
The company’s devices fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) clearance through the FDA. Products are listed in the FDA’s 510(k) registry, reflecting their authorised status for commercial distribution. The manufacturer operates from the United States.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does Cardiodynamics International Corp. have in the registry?
The registry currently lists 11 devices for Cardiodynamics International Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiodynamics International Corp.'s devices?
Among its 11 most recently registered devices, Cardiodynamics International Corp. has devices listed in FDA 510(k) (11 devices).
What risk classes do Cardiodynamics International Corp.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Cardiodynamics International Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiodynamics International Corp. in the registry?
The most recently registered devices listed for Cardiodynamics International Corp. include BIOZ.COM SYSTEM, BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100, BIOZ SYSTEM & BIOZ PORTABLE and BIOZ SYSTEM.