Rtx Healthcare A/S
DenmarkFDA applicant, unverified
- Devices
- 3
What Rtx Healthcare A/S makes
Rtx Healthcare A/S manufactures medical monitoring and telehealth devices, including the DLM112 DayLink Monitor for patient data tracking and the RTX3320PSTN wireless telehealth gateway for remote connectivity. The RTX3370 is also part of its portfolio, likely serving as a specialized telehealth or monitoring unit.
These devices fall under FDA Class II regulation and are listed via 510(k) clearance in the United States. The company is based in the US, with its products authorised through the FDA’s regulatory pathways.
Catalogue
DLM112 Daylink Monitor Ref K062304
Regimes: 510(k) Registry: 510(k)RTX3320PSTN Wireless Telehealth Gateway Ref K041816
Regimes: 510(k) Registry: 510(k)RTX3370 Ref K071953
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rtx Healthcare A/S have in the registry?
The registry currently lists 3 devices for Rtx Healthcare A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rtx Healthcare A/S's devices?
Among its 3 most recently registered devices, Rtx Healthcare A/S has devices listed in FDA 510(k) (3 devices).
What risk classes do Rtx Healthcare A/S's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Rtx Healthcare A/S's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rtx Healthcare A/S in the registry?
The most recently registered devices listed for Rtx Healthcare A/S include DLM112 DAYLINK MONITOR, RTX3320PSTN WIRELESS TELEHEALTH GATEWAY and RTX3370.