K930599 is an FDA 510(k) clearance for the BODY FAT ANALYZER MODEL TBF-105. This device is classified as a Plethysmograph, Impedance (Class II - Special Controls, product code DSB).
Submitted by Tanita Corp. of America (Skokie, US). The FDA issued a Cleared decision on November 1, 1994, 634 days after receiving the submission on February 5, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K930599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1993 |
| Decision Date | November 01, 1994 |
| Days to Decision | 634 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DSB — Plethysmograph, Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |