The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Vigilance Cco/cedv & Vigilance Cco/svo2/cedv Monitors.
| Device ID | K000664 |
| 510k Number | K000664 |
| Device Name: | VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Contact | Paula A Torrianni |
| Correspondent | Paula A Torrianni BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-09-20 |