Prym Medical, Ltd.
IsraelFDA applicant, unverified
- Devices
- 2
What Prym Medical, Ltd. makes
Prym Medical, Ltd. manufactures continuous positive airway pressure (CPAP) systems, including the Dornir LC-1 and Sansibar CPAP systems, designed for respiratory therapy in sleep-related breathing disorders.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Dornir Lc-1 Cpap System Ref K010704
Regimes: 510(k) Registry: 510(k)Sansibar Cpap System Ref K000888
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Prym Medical, Ltd. have in the registry?
The registry currently lists 2 devices for Prym Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prym Medical, Ltd.'s devices?
Among its 2 most recently registered devices, Prym Medical, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Prym Medical, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Prym Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prym Medical, Ltd. in the registry?
The most recently registered devices listed for Prym Medical, Ltd. include DORNIR LC-1 CPAP SYSTEM and SANSIBAR CPAP SYSTEM.