The following data is part of a premarket notification filed by Oximetrix, Inc. with the FDA for Heater, Oximeter System.
| Device ID | K781879 |
| 510k Number | K781879 |
| Device Name: | HEATER, OXIMETER SYSTEM |
| Classification | Oximeter |
| Applicant | OXIMETRIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-06 |
| Decision Date | 1979-01-08 |