The following data is part of a premarket notification filed by Oximetrix, Inc. with the FDA for Oximetrix Accu Sat Cpb.
| Device ID | K811391 |
| 510k Number | K811391 |
| Device Name: | OXIMETRIX ACCU SAT CPB |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | OXIMETRIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-18 |
| Decision Date | 1981-07-20 |