Bluezone Model RX-450 Air Purifier

Bluezone Model RX-450 Air Purifier is an FDA 510(k)-cleared medical device (K212824) manufactured by Bluezone Products, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 16, 2022. Regulation: 8.