K020738 is an FDA 510(k) clearance for the AVITA BF1 (VITALIO) BODY FAT ANALYZER. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Avita Corporation (Flagstaff, US). The FDA issued a Cleared decision on May 22, 2003, 442 days after receiving the submission on March 6, 2002.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K020738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2002 |
| Decision Date | May 22, 2003 |
| Days to Decision | 442 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 |