The following data is part of a premarket notification filed by Tanita Corp. Of America with the FDA for Body Fat Analyzer Model Tbf-105.
Device ID | K930599 |
510k Number | K930599 |
Device Name: | BODY FAT ANALYZER MODEL TBF-105 |
Classification | Plethysmograph, Impedance |
Applicant | TANITA CORP. OF AMERICA 5200 CHURCH ST. Skokie, IL 60077 |
Contact | Toshihiko Oshima |
Correspondent | Toshihiko Oshima TANITA CORP. OF AMERICA 5200 CHURCH ST. Skokie, IL 60077 |
Product Code | DSB |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-05 |
Decision Date | 1994-11-01 |