The following data is part of a premarket notification filed by Oximetrix, Inc. with the FDA for Catheter, Thermal Dilution Fiberoptic.
| Device ID | K781134 |
| 510k Number | K781134 |
| Device Name: | CATHETER, THERMAL DILUTION FIBEROPTIC |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | OXIMETRIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-06 |
| Decision Date | 1978-08-17 |