The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning 965 Carbon Dioxide Analyzer.
| Device ID | K811257 |
| 510k Number | K811257 |
| Device Name: | CORNING 965 CARBON DIOXIDE ANALYZER |
| Classification | Coulometric Method, Carbon-dioxide |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-05 |
| Decision Date | 1981-05-27 |