K172259 is an FDA 510(k) clearance for the PulsioFlex Monitoring System. This device is classified as a Computer, Diagnostic, Pre-programmed, Single-function (Class II - Special Controls, product code DXG).
Submitted by Pulsion Medical Systems SE (Feldkirchen, DE). The FDA issued a Cleared decision on January 18, 2018, 175 days after receiving the submission on July 27, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K172259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2017 |
| Decision Date | January 18, 2018 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXG - Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1435 |