The following data is part of a premarket notification filed by Oximetrix, Inc. with the FDA for Model 3000 Opticath Computer.
| Device ID | K853018 |
| 510k Number | K853018 |
| Device Name: | MODEL 3000 OPTICATH COMPUTER |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | OXIMETRIX, INC. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Contact | Michael J Billig |
| Correspondent | Michael J Billig OXIMETRIX, INC. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-17 |
| Decision Date | 1986-01-13 |