Holter Data Services
Country not established
- Devices
- 1
What Holter Data Services makes
Holter Data Services manufactures Holter monitoring systems, specifically the HOLTER ST SYSTEM (Model No. 5000-20), designed for continuous electrocardiographic (ECG) recording to detect cardiac arrhythmias over extended periods.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Holter St System, Model No. 5000-20 Ref K871389
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Holter Data Services have in the registry?
The registry currently lists 1 device for Holter Data Services. Devices recorded under merged duplicate company entries are counted once.
Which registries list Holter Data Services's devices?
Among its 1 most recently registered device, Holter Data Services has devices listed in FDA 510(k) (1 device).
What risk classes do Holter Data Services's devices fall under?
Among its 1 most recently registered device, the classes recorded for Holter Data Services's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Holter Data Services in the registry?
The most recently registered devices listed for Holter Data Services include HOLTER ST SYSTEM, MODEL NO. 5000-20.