Specwell
36 catalogue numbers from M820-C, listed by Specwell Corporation, Japan, under Telescope, Hand-Held, Low-Vision. 1 manufacturer in China is registered for this product code.
Telescope, Hand-Held, Low-Vision
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Anhui.
What Is FDA Product Code HKB?
Telescope, Hand-Held, Low-Vision is FDA product code HKB, Class 1, 21 CFR 886.5870.
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.
Name
Record