Vectorcardiograph
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong.
- Edan Instruments, Inc. Guangdong, contract manufacturer
How Is DYC Classified?
Vectorcardiograph is FDA product code DYC, Class 2, 21 CFR 870.2400.
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.