510(k) K001488

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

K001488 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "NARKOMED MRI , NM-MRI". The FDA issued a decision of Substantially Equivalent on June 9, 2000. 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.