Labtech Kft.
HungaryFDA applicant, unverified
- Devices
- 1
What Labtech Kft. makes
Labtech Kft. manufactures Cardiospy ECG Holter Systems, which are portable, continuous monitoring devices designed to record the heart’s electrical activity over extended periods for diagnostic evaluation of arrhythmias and other cardiac conditions.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. The company is based in the United States.
Catalogue
Cardiospy Ecg Holter Systems Ref K140847
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Labtech Kft. have in the registry?
The registry currently lists 1 device for Labtech Kft.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Labtech Kft.'s devices?
Among its 1 most recently registered device, Labtech Kft. has devices listed in FDA 510(k) (1 device).
What risk classes do Labtech Kft.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Labtech Kft.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Labtech Kft. in the registry?
The most recently registered devices listed for Labtech Kft. include CARDIOSPY ECG HOLTER SYSTEMS.