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The Prep-Check 10Hz is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes a applied to patients. This version measures impedance at…
Tester, Electrode, Surface, Electrocardiographic
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Guangdong: 2 hold an FDA registration. 1 is a contract manufacturer.
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Guangdong
What Is FDA Product Code KRC?
Tester, Electrode, Surface, Electrocardiographic is FDA product code KRC, Class 2, 21 CFR 870.2370.
What Does It Take to Sell It in the United States?
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.