The following data is part of a premarket notification filed by Gardner Cryogenics with the FDA for Blood Gas Analyzer-calibration Gas.
| Device ID | K770494 |
| 510k Number | K770494 |
| Device Name: | BLOOD GAS ANALYZER-CALIBRATION GAS |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | GARDNER CRYOGENICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-03-14 |
| Decision Date | 1977-04-15 |