Parama-Tech Company., Ltd.
Country not established
- Devices
- 1
What Parama-Tech Company., Ltd. makes
Parama-Tech Company, Ltd. manufactures the PALM ECG RECORDER (models EP-201 and EP-202), a portable device designed for electrocardiogram recording and analysis. These recorders are intended for use in capturing and storing heart rhythm data, typically for clinical or diagnostic purposes.
The company’s ECG recorders fall under FDA Class II devices and are listed via the 510(k) pathway. These devices are regulated under US jurisdiction, adhering to the requirements of the FDA’s medical device clearance process.
Catalogue
Palm Ecg Recorder, Model Ep-201/202 Ref K061123
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Parama-Tech Company., Ltd. have in the registry?
The registry currently lists 1 device for Parama-Tech Company., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Parama-Tech Company., Ltd.'s devices?
Among its 1 most recently registered device, Parama-Tech Company., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Parama-Tech Company., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Parama-Tech Company., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Parama-Tech Company., Ltd. in the registry?
The most recently registered devices listed for Parama-Tech Company., Ltd. include PALM ECG RECORDER, MODEL EP-201/202.