The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Vigilance Continuous Cardiac Output/oximetry (cco/svo2) Monitor.
| Device ID | K955816 |
| 510k Number | K955816 |
| Device Name: | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR |
| Classification | Catheter, Flow Directed |
| Applicant | BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Contact | Irene P Parker |
| Correspondent | Irene P Parker BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1997-05-06 |
| Summary: | summary |