K192169 is an FDA 510(k) clearance for the PulsioFlex Monitoring System with ProAQT Sensor. 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 April 30, 2020, 265 days after receiving the submission on August 9, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K192169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2019 |
| Decision Date | April 30, 2020 |
| Days to Decision | 265 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 |