Computerized Cognitive Assessment Aid, Exempt

What Is This Device?

This product code is the class II exempt counterpart of PKQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 882.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

What Is FDA Product Code PTY?

Computerized Cognitive Assessment Aid, Exempt is FDA product code PTY, Class 2, 21 CFR 882.1470.

What Does It Take to Sell It in the United States?

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.