K222982 is an FDA 510(k) clearance for the Virtus Metabolic Monitor. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Virtus Technology Aps (Roennede, DK). The FDA issued a Cleared decision on June 23, 2023, 268 days after receiving the submission on September 28, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K222982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2022 |
| Decision Date | June 23, 2023 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTY - Calculator, Predicted Values, Pulmonary Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |