Stein-Gates Medical Equipment, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Stein-Gates Medical Equipment, Inc. makes
Stein-Gates Medical Equipment, Inc. manufactures mechanical ventilators, including the OMNI-VENT Series D and its MRI-compatible variant, designed for patient respiratory support in clinical settings.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
Omni-Vent, Series D Ref K872113
Regimes: 510(k) Registry: 510(k)Omni-Vent, Series D/Mri Ref K881420
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stein-Gates Medical Equipment, Inc. have in the registry?
The registry currently lists 2 devices for Stein-Gates Medical Equipment, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stein-Gates Medical Equipment, Inc.'s devices?
Among its 2 most recently registered devices, Stein-Gates Medical Equipment, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Stein-Gates Medical Equipment, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Stein-Gates Medical Equipment, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stein-Gates Medical Equipment, Inc. in the registry?
The most recently registered devices listed for Stein-Gates Medical Equipment, Inc. include OMNI-VENT, SERIES D and OMNI-VENT, SERIES D/MRI.