ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)

ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) is an FDA 510(k)-cleared medical device (K965016) manufactured by Gibeck, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 1997. Regulation: 8.