510(k) K990968

E-SCAN by Biosound Esaote, Inc. — Product Code LNH

K990968 is an FDA 510(k) premarket notification submitted by Biosound Esaote, Inc. for the device "E-SCAN". The FDA issued a decision of Substantially Equivalent on May 27, 1999. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Biosound Esaote, Inc. has at least 10 other 510(k) clearances on record.