Avologi Gel Primer (Model: Av25)

Avologi Gel Primer (Model: Av25) is an FDA 510(k)-cleared medical device (K220735) manufactured by Premier North America, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2023. Regulation: 8.