510(k) K042528

INBODY, MODEL 3.0 by Biospace Corporation Limited — Product Code MNW

K042528 is an FDA 510(k) premarket notification submitted by Biospace Corporation Limited for the device "INBODY, MODEL 3.0". The FDA issued a decision of Substantially Equivalent on January 11, 2005. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Biospace Corporation Limited has at least 8 other 510(k) clearances on record.