Gazelle Corp.
Country not established
- Devices
- 2
What Gazelle Corp. makes
Gazelle Corp. manufactures magnifying tools for visual assistance, including plastic or glass magnifiers and magnifying spectacles with plastic lenses. These devices are designed to enhance visibility for tasks requiring detailed inspection or reading.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the 510(k) clearance database. The portfolio is regulated in the United States.
Catalogue
Plastic Or Glass Magnifier Ref K820375
Regimes: 510(k) Registry: 510(k)Magnifying Spectacles W/Plastic Lenses Ref K844716
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gazelle Corp. have in the registry?
The registry currently lists 2 devices for Gazelle Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gazelle Corp.'s devices?
Among its 2 most recently registered devices, Gazelle Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Gazelle Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gazelle Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Gazelle Corp. in the registry?
The most recently registered devices listed for Gazelle Corp. include PLASTIC OR GLASS MAGNIFIER and MAGNIFYING SPECTACLES W/PLASTIC LENSES.