The following data is part of a premarket notification filed by Tanita Corp. Of America with the FDA for Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale.
| Device ID | K014009 |
| 510k Number | K014009 |
| Device Name: | TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE |
| Classification | Analyzer, Body Composition |
| Applicant | TANITA CORP. OF AMERICA 2625 SOUTH CLEARBROOK DR. Arlington Hgts., IL 60005 |
| Contact | Carol Alloian (benson) |
| Correspondent | Carol Alloian (benson) 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 | 2001-12-05 |
| Decision Date | 2002-06-24 |
| Summary: | summary |