Vit Kit- Freeze NX and Vit Kit- Warm NX

Vit Kit- Freeze NX and Vit Kit- Warm NX is an FDA 510(k)-cleared medical device (K190152) manufactured by Fujifilm Irvine Scientific, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2019. Regulation: 8.