K183567 is an FDA 510(k) clearance for the Vyntus/SentrySuite Product Line. This device is classified as a Calculator, Pulmonary Function Data (Class II - Special Controls, product code BZC).
Submitted by Vyaire Medical (Hoechber, DE). The FDA issued a Cleared decision on August 23, 2019, 245 days after receiving the submission on December 21, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1880.
| 510(k) Number | K183567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2018 |
| Decision Date | August 23, 2019 |
| Days to Decision | 245 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 |