K052646 is an FDA 510(k) clearance for the BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Biospace Corporation Limited (Deer Field, US). The FDA issued a Cleared decision on December 16, 2005, 81 days after receiving the submission on September 26, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K052646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2005 |
| Decision Date | December 16, 2005 |
| Days to Decision | 81 days |
| Submission Type | Special |
| 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 |