Nirad, Ltd.
IrelandFDA applicant, unverified
- Devices
- 2
What Nirad, Ltd. makes
Nirad, Ltd. manufactures cardiac monitoring devices, including the NR5000 ECG and pulse oximeter monitor for real-time heart rhythm and oxygen saturation tracking, as well as the NR2000 standalone cardiac monitor for continuous heart function observation.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) clearance pathway. Nirad, Ltd. is based in the United States.
Catalogue
NR5000 E.C.G. And Pulse Oximeter Monitor Ref K894919
Regimes: 510(k) Registry: 510(k)NR2000 Cardiac Monitor Ref K883903
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nirad, Ltd. have in the registry?
The registry currently lists 2 devices for Nirad, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nirad, Ltd.'s devices?
Among its 2 most recently registered devices, Nirad, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Nirad, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Nirad, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nirad, Ltd. in the registry?
The most recently registered devices listed for Nirad, Ltd. include NR5000 E.C.G. AND PULSE OXIMETER MONITOR and NR2000 CARDIAC MONITOR.