Non-Normalizing Quantitative Electroencephalograph Software

What Is This Device?

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

How Is OLT Classified?

Non-Normalizing Quantitative Electroencephalograph Software is FDA product code OLT, Class 2, 21 CFR 882.1400.

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.