K040778 is an FDA 510(k) clearance for the TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9). 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 December 23, 2004, 272 days after receiving the submission on March 26, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K040778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2004 |
| Decision Date | December 23, 2004 |
| Days to Decision | 272 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 |