Simbionix, Ltd.
Country not established
- Devices
- 3
What Simbionix, Ltd. makes
Simbionix, Ltd. manufactures Procedure Rehearsal Studio systems, which are simulation platforms designed for medical training and procedural practice in clinical settings.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Procedure Rehearsal Studio Ref K093269
Regimes: 510(k) Registry: 510(k)Procedure Rehearsal Studio Ref K123269
Regimes: 510(k) Registry: 510(k)Procedure Rehearsal Studio(Tm) Ref K112387
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Simbionix, Ltd. have in the registry?
The registry currently lists 3 devices for Simbionix, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Simbionix, Ltd.'s devices?
Among its 3 most recently registered devices, Simbionix, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Simbionix, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Simbionix, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Simbionix, Ltd. in the registry?
The most recently registered devices listed for Simbionix, Ltd. include PROCEDURE REHEARSAL STUDIO and PROCEDURE REHEARSAL STUDIO(TM).