The following data is part of a premarket notification filed by Tanita Corporation Of America with the FDA for Tanita Body Composition Analyzer, Model Sc-331.
| Device ID | K090479 |
| 510k Number | K090479 |
| Device Name: | TANITA BODY COMPOSITION ANALYZER, MODEL SC-331 |
| Classification | Analyzer, Body Composition |
| Applicant | TANITA CORPORATION OF AMERICA 2625 SOUTH CLEARBROOK DRIVE Arlington Heights, IL 60005 |
| Contact | Toshihiko Ishikawa |
| Correspondent | Toshihiko Ishikawa TANITA CORPORATION OF AMERICA 2625 SOUTH CLEARBROOK DRIVE Arlington Heights, IL 60005 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-24 |
| Decision Date | 2009-07-07 |
| Summary: | summary |