510(k) K954828

ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT by Gibeck, Inc. — Product Code CAH

K954828 is an FDA 510(k) premarket notification submitted by Gibeck, Inc. for the device "ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT". The FDA issued a decision of Substantially Equivalent on May 2, 1996. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Gibeck, Inc. has at least 10 other 510(k) clearances on record.