The following data is part of a premarket notification filed by Tanita Corp. Of America with the FDA for Tanita Scale Plus Body Fat Monitor With Body Water Percentage.
| Device ID | K040978 |
| 510k Number | K040978 |
| Device Name: | TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE |
| Classification | Analyzer, Body Composition |
| Applicant | TANITA CORP. OF AMERICA 2625 CLEARBROOK DR. Arlington Hgts., IL 60005 |
| Contact | Rhoda L Valera |
| Correspondent | Chantel Carson UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-15 |
| Decision Date | 2004-07-22 |
| Summary: | summary |