The following data is part of a premarket notification filed by Pulsion Medical Systems Ag with the FDA for Pulsion Picco2 (8500), Cevox Optical Module (pc3015), Cevox Disposable Probes (pv2022-30 Thru -38, Pv2022-46 Thru -48).
| Device ID | K091786 |
| 510k Number | K091786 |
| Device Name: | PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | PULSION MEDICAL SYSTEMS AG 7220 SPARHAWK RD. Wake Forest, NC 27587 |
| Contact | Jamie Sulley |
| Correspondent | Jamie Sulley PULSION MEDICAL SYSTEMS AG 7220 SPARHAWK RD. Wake Forest, NC 27587 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2010-06-18 |
| Summary: | summary |