K122121 is an FDA 510(k) clearance for the PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE. 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 (Westbrook, US). The FDA issued a Cleared decision on August 2, 2012, 16 days after receiving the submission on July 17, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K122121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2012 |
| Decision Date | August 02, 2012 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXG - Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1435 |