The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning 2500 Co-oximeter.
| Device ID | K830590 |
| 510k Number | K830590 |
| Device Name: | CORNING 2500 CO-OXIMETER |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-24 |
| Decision Date | 1983-04-05 |