K181912 is an FDA 510(k) clearance for the Ascent Cardiorespiratory Diagnostic Software. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Medical Graphics Corporation (St. Paul, US). The FDA issued a Cleared decision on April 12, 2019, 269 days after receiving the submission on July 17, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K181912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2018 |
| Decision Date | April 12, 2019 |
| Days to Decision | 269 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 |