510(k) K040778

TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) by Tanita Corp. of America — Product Code MNW

K040778 is an FDA 510(k) premarket notification submitted by Tanita Corp. of America for the device "TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)". The FDA issued a decision of Substantially Equivalent on December 23, 2004. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Tanita Corp. of America has at least 5 other 510(k) clearances on record.