510(k) K080117

PATIENT ISOLATION UNIT, MODEL G019-1000 by Gentex Corporation — Product Code LGM

K080117 is an FDA 510(k) premarket notification submitted by Gentex Corporation for the device "PATIENT ISOLATION UNIT, MODEL G019-1000". The FDA issued a decision of Substantially Equivalent on January 30, 2009. The device falls under product code LGM (Chamber, Patient Isolation), a Class II device regulated under 21 CFR 880.5450. Gentex Corporation has at least 2 other 510(k) clearances on record.