The following data is part of a premarket notification filed by Pulsion Medical Systems, Inc. with the FDA for Pulsion Continuous Pulse Contour Cardiac Output (picco) System.
| Device ID | K001762 |
| 510k Number | K001762 |
| Device Name: | PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | PULSION MEDICAL SYSTEMS, INC. 20462-A CHARTWELL CENTER DR. PO BOX 2637 Cornelius, NC 28031 |
| Contact | Ulf Borg |
| Correspondent | Ulf Borg PULSION MEDICAL SYSTEMS, INC. 20462-A CHARTWELL CENTER DR. PO BOX 2637 Cornelius, NC 28031 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-09 |
| Decision Date | 2000-06-13 |