The following data is part of a premarket notification filed by Tanita Corp. Of America with the FDA for Tanita Segmental Body Composition Analyzer, Model Bc-418.
| Device ID | K033157 |
| 510k Number | K033157 |
| Device Name: | TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 |
| Classification | Analyzer, Body Composition |
| Applicant | TANITA CORP. OF AMERICA 2625 SOUTH CLEARBROOK DR. Arlington Hgts., IL 60005 |
| Contact | Rhoda Lynn Valera |
| Correspondent | Rhoda Lynn Valera TANITA CORP. OF AMERICA 2625 SOUTH CLEARBROOK DR. Arlington Hgts., 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 | 2003-09-30 |
| Decision Date | 2004-04-08 |
| Summary: | summary |