K231116 is an FDA 510(k) clearance for the Multi-parameter detector. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on June 15, 2024, 422 days after receiving the submission on April 20, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K231116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2023 |
| Decision Date | June 15, 2024 |
| Days to Decision | 422 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MNW - Analyzer, Body Composition |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |