K213863 is an FDA 510(k) clearance for the Everion+ System. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Biofourmis Singapore Pte., Ltd. (Singapore, SG). The FDA issued a Cleared decision on February 23, 2023, 440 days after receiving the submission on December 10, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K213863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2021 |
| Decision Date | February 23, 2023 |
| Days to Decision | 440 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MSX - System, Network And Communication, Physiological Monitors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |