Cardio-Scan of Texas
Country not established
- Devices
- 1
What Cardio-Scan of Texas makes
Cardio-Scan of Texas manufactures the Data IV Ambulatory Monitor, a portable device designed for continuous, long-term recording of cardiac electrical activity outside of a clinical setting. It is intended for use in diagnosing arrhythmias, ischemia, and other cardiac conditions by capturing and storing ECG data for later analysis.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance for market authorisation. The Data IV Ambulatory Monitor is listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
Data Iv Ambulatory Monitor Ref K831262
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardio-Scan of Texas have in the registry?
The registry currently lists 1 device for Cardio-Scan of Texas. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio-Scan of Texas's devices?
Among its 1 most recently registered device, Cardio-Scan of Texas has devices listed in FDA 510(k) (1 device).
What risk classes do Cardio-Scan of Texas's devices fall under?
Among its 1 most recently registered device, the classes recorded for Cardio-Scan of Texas's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardio-Scan of Texas in the registry?
The most recently registered devices listed for Cardio-Scan of Texas include DATA IV AMBULATORY MONITOR.