510(k) K930599

BODY FAT ANALYZER MODEL TBF-105 by Tanita Corp. of America — Product Code DSB

K930599 is an FDA 510(k) premarket notification submitted by Tanita Corp. of America for the device "BODY FAT ANALYZER MODEL TBF-105". The FDA issued a decision of Substantially Equivalent on November 1, 1994. The device falls under product code DSB (Plethysmograph, Impedance), 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
November 1, 1994
Date Received
February 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type