Level 1
Catalogue number ES100-9, listed by ICU Medical, Inc, United States, under Stethoscope, Esophageal. 1 manufacturer in China is registered for this product code.
Stethoscope, Esophageal
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
What Is FDA Product Code BZW?
Stethoscope, Esophageal is FDA product code BZW, Class 1, 21 CFR 868.1910.
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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