The following data is part of a premarket notification filed by Pulsion Medical Systems Ag with the FDA for Pulsion Picco Plus, Model 8100.
| Device ID | K060898 |
| 510k Number | K060898 |
| Device Name: | PULSION PICCO PLUS, MODEL 8100 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | PULSION MEDICAL SYSTEMS AG P.O. BOX 99033 Raleigh, NC 27624 |
| Contact | Jamie Sulley |
| Correspondent | Jamie Sulley PULSION MEDICAL SYSTEMS AG P.O. BOX 99033 Raleigh, NC 27624 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2006-07-25 |
| Summary: | summary |