510(k) K883621

INSTRUMENTARIUM ULF MR IMAGING SYSTEM by Instrumentarium Corp. — Product Code LNH

K883621 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "INSTRUMENTARIUM ULF MR IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 10, 1988. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.