SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM

SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM is an FDA 510(k)-cleared medical device (K912909) manufactured by Air-Shields Vickers, 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 4, 1991. Regulation: 8.