The following data is part of a premarket notification filed by Pulsion Medical Systems Se with the FDA for Pulsioflex Monitoring System.
| Device ID | K172259 |
| 510k Number | K172259 |
| Device Name: | PulsioFlex Monitoring System |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | PULSION Medical Systems SE Hans-Riedl-Str. 17 Feldkirchen, DE 85622 |
| Contact | Marc Bergenthal |
| Correspondent | Mark Smith Maquet Cardiovascular 45 Barbour Pond Drive Wayne, NJ 07470 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-27 |
| Decision Date | 2018-01-18 |
| Summary: | summary |