ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM

ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM is an FDA 510(k)-cleared medical device (K012549) manufactured by Healthway 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 3, 2002. Regulation: 8.