ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT

ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT is an FDA 510(k)-cleared medical device (K954828) 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 May 1, 1996. Regulation: 8.