510(k) K033157

TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 by Tanita Corp. of America — Product Code MNW

K033157 is an FDA 510(k) premarket notification submitted by Tanita Corp. of America for the device "TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418". The FDA issued a decision of Substantially Equivalent on April 8, 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
April 8, 2004
Date Received
September 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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