AMA Optics Amblyometer
An ophthalmic device for binocular vision testing. The patient views a two image pairs stacked (Top = right dim image/left bright image; Bottom = right bright image//left dim image) through…
Instrument, Measuring, Stereopsis
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
- 66 Vision Tech Co., Ltd. Jiangsu
How Is HLC Classified?
Instrument, Measuring, Stereopsis is FDA product code HLC, Class 1, 21 CFR 886.1460.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.