Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
GAS Sampling Line, Disposable, PVC/PE, 2M/7FT, 1 PCS
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
Who Makes This Device Type in China?
5 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Jiangsu. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
- Edan Instruments, Inc. Guangdong, contract manufacturer
- GE Medical Systems (China) Co., Ltd. Jiangsu, contract manufacturer
- Shenzhen Comen Medical Instruments Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Guangdong
What Is It?
A desflurane gas analyzer is a device intended to measure the concentration of desflurane anesthetic in a gas mixture.
What Is FDA Product Code NHO?
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) is FDA product code NHO, Class 2, 21 CFR 868.1500.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.
A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
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