The following data is part of a premarket notification filed by Kli with the FDA for Co2 Cystoscopy/urethroscopy Console.
| Device ID | K800822 |
| 510k Number | K800822 |
| Device Name: | CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | KLI 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-14 |
| Decision Date | 1980-06-17 |