Randwal Instrument Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Randwal Instrument Co., Inc. makes
Randwal Instrument Co., Inc. manufactures diagnostic ophthalmic devices, including the IRAS GLARE TESTER for evaluating visual glare response, the IRAS PERIMETER for assessing visual field boundaries, and the IRAS EDS INTERFEROMETRIC STIMULATOR for retinal imaging. Their portfolio also includes laser-based systems like the LASER IRAS and diagnostic laser interferometers, such as the VARIABLE CONTRAST ACUIOMETER. Portable acuiometers for visual acuity testing are also part of their offerings.
The company’s devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. Their products are based in the United States.
Catalogue
Iras Glare Tester Ref K873987
Regimes: 510(k) Registry: 510(k)Iras Perimeter Ref K864012
Regimes: 510(k) Registry: 510(k)Iras Eds Interferometric Stimulator Ref K873990
Regimes: 510(k) Registry: 510(k)Laser Iras Ref K853556
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Portable Acuiometer Ref K842567
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Randwal Instrument Co., Inc. have in the registry?
The registry currently lists 6 devices for Randwal Instrument Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Randwal Instrument Co., Inc.'s devices?
Among its 6 most recently registered devices, Randwal Instrument Co., Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Randwal Instrument Co., Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Randwal Instrument Co., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Randwal Instrument Co., Inc. in the registry?
The most recently registered devices listed for Randwal Instrument Co., Inc. include IRAS GLARE TESTER, IRAS PERIMETER, IRAS EDS INTERFEROMETRIC STIMULATOR and LASER IRAS.