BluHale PRO™
Catalogue number PRO-MKC, listed by Mannkind Corporation, United States, under Transducer, Gas Pressure, Differential. 1 manufacturer in China is registered for this product code.
Transducer, Gas Pressure, Differential
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
What Is FDA Product Code BYR?
Transducer, Gas Pressure, Differential is FDA product code BYR, Class 1, 21 CFR 868.2875.
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.