510(k) K041622

MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM by Draeger Medical, Inc. — Product Code BSZ

K041622 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 2004. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Draeger Medical, Inc. has at least 10 other 510(k) clearances on record.