The following data is part of a premarket notification filed by Rna Medical Corp. with the FDA for Blood Gas Solutions & Co-oximeter Solu-.
| Device ID | K830843 |
| 510k Number | K830843 |
| Device Name: | BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- |
| Classification | Gas Chromatograph, Carbon-monoxide |
| Applicant | RNA MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKT |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-17 |
| Decision Date | 1983-04-28 |