MODEL BION 2/TYPE 90 ROOM IONIZER

MODEL BION 2/TYPE 90 ROOM IONIZER is an FDA 510(k)-cleared medical device (K851358) manufactured by Medicor USA , Ltd.. 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 June 30, 1985. Regulation: 8.