K014009 is an FDA 510(k) clearance for the TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Tanita Corp. of America (Arlington Heights, US). The FDA issued a Cleared decision on June 24, 2002, 201 days after receiving the submission on December 5, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K014009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2001 |
| Decision Date | June 24, 2002 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MNW — Analyzer, Body Composition |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |