The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Venous Oxygen Probe.
| Device ID | K811071 |
| 510k Number | K811071 |
| Device Name: | VENOUS OXYGEN PROBE |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | G.D. SEARLE AND CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCE |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-20 |
| Decision Date | 1981-05-05 |