510(k) K003579

NARKOMED MRI-2, MODEL NM-MRI-2 by Draeger Medical, Inc. — Product Code BSZ

K003579 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "NARKOMED MRI-2, MODEL NM-MRI-2". The FDA issued a decision of Substantially Equivalent on January 22, 2001. 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.