510(k) K040978

TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE by Tanita Corp. of America — Product Code MNW

K040978 is an FDA 510(k) premarket notification submitted by Tanita Corp. of America for the device "TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE". The FDA issued a decision of Substantially Equivalent on July 22, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2004
Date Received
April 15, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Analyzer, Body Composition
Device Class
Class II
Regulation Number
870.2770
Review Panel
GU
Submission Type