K190853 is an FDA 510(k) clearance for the Vyntus BODY. This device is classified as a Calculator, Pulmonary Function Data (Class II - Special Controls, product code BZC).
Submitted by Vyaire Medical, Inc. (Mettawa, US). The FDA issued a Cleared decision on August 16, 2019, 136 days after receiving the submission on April 2, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1880.
| 510(k) Number | K190853 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2019 |
| Decision Date | August 16, 2019 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZC - Calculator, Pulmonary Function Data |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1880 |