Versamed, Ltd.
IsraelFDA applicant, unverified
- Devices
- 3
What Versamed, Ltd. makes
Versamed, Ltd. manufactures portable ventilators, including the IVENT 201 and SMARTVENT 201 models, designed for use in both clinical and home settings to provide mechanical ventilation support.
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
Ivent 201 Portable Ventilator Ref K021981
Regimes: 510(k) Registry: 510(k)Ivent 201 Portable Ventilator Ref K011957
Regimes: 510(k) Registry: 510(k)Smartvent 201 Portable Ventilator Ref K981668
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Versamed, Ltd. have in the registry?
The registry currently lists 3 devices for Versamed, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Versamed, Ltd.'s devices?
Among its 3 most recently registered devices, Versamed, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Versamed, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Versamed, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Versamed, Ltd. in the registry?
The most recently registered devices listed for Versamed, Ltd. include IVENT 201 PORTABLE VENTILATOR and SMARTVENT 201 PORTABLE VENTILATOR.