Versamed Medical Systems, Ltd.
Country not established
- Devices
- 8
What Versamed Medical Systems, Ltd. makes
Versamed Medical Systems produces non-invasive ventilators, including the IVENT101 and its modified versions, designed for respiratory support in clinical settings. These devices are intended for patients requiring mechanical ventilation, offering adjustable pressure and flow settings to manage breathing assistance.
The company’s ventilators fall under FDA Class II regulation, requiring 510(k) clearance for market authorisation in the US. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with US regulatory requirements.
Catalogue
Modification To: Ivent 201 Portable Ventilator Ref K052554
Regimes: 510(k) Registry: 510(k)Ivent 2001 Mri Conditional Ref K073694
Regimes: 510(k) Registry: 510(k)IVENT101 Ref K112754
Regimes: 510(k) Registry: 510(k)IVENT101 Ref K081845
Regimes: 510(k) Registry: 510(k)Modification To I Vent 201 Ref K061627
Regimes: 510(k) Registry: 510(k)Ivent 201 Ref K053270
Regimes: 510(k) Registry: 510(k)Ivent 201 Portable Ventilator Ref K042468
Regimes: 510(k) Registry: 510(k)Modification To Ivent 101 Ref K092135
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Versamed Medical Systems, Ltd. have in the registry?
The registry currently lists 8 devices for Versamed Medical Systems, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Versamed Medical Systems, Ltd.'s devices?
Among its 8 most recently registered devices, Versamed Medical Systems, Ltd. has devices listed in FDA 510(k) (8 devices).
What risk classes do Versamed Medical Systems, Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Versamed Medical Systems, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Versamed Medical Systems, Ltd. in the registry?
The most recently registered devices listed for Versamed Medical Systems, Ltd. include MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR, IVENT 2001 MRI CONDITIONAL, IVENT101 and MODIFICATION TO I VENT 201.