Gamut Ent.
Country not established
- Devices
- 1
What Gamut Ent. makes
Gamut Ent. manufactures the JedMed/Pollack Keratoscope HS/SL, a device used for corneal topography to map the curvature of the eye’s anterior surface for diagnostic and preoperative assessment.
The keratoscope is classified as a Class I medical device under FDA regulations and is listed via a 510(k) submission. The company is based in the United States.
Catalogue
Jedmed/Polack Keratoscope Hs/Sl Ref K882618
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gamut Ent. have in the registry?
The registry currently lists 1 device for Gamut Ent.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gamut Ent.'s devices?
Among its 1 most recently registered device, Gamut Ent. has devices listed in FDA 510(k) (1 device).
What risk classes do Gamut Ent.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Gamut Ent.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Gamut Ent. in the registry?
The most recently registered devices listed for Gamut Ent. include JEDMED/POLACK KERATOSCOPE HS/SL.