The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Oximetry Probe Catheters.
| Device ID | K901736 |
| 510k Number | K901736 |
| Device Name: | OXIMETRY PROBE CATHETERS |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Douglas, Phd |
| Correspondent | Douglas, Phd BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-17 |
| Decision Date | 1990-09-11 |