System, Signal Isolation
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Guangdong. 1 is a contract manufacturer.
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
What Is FDA Product Code DRJ?
System, Signal Isolation is FDA product code DRJ, Class 1, 21 CFR 870.2600.
How Does It Reach the US Market?
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.
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