APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM

APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM is an FDA 510(k)-cleared medical device (K963510) manufactured by Mellen Air Mfg., 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 November 25, 1996. Regulation: 8.