The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Monitor, Oxychek Oxygen.
| Device ID | K782114 |
| 510k Number | K782114 |
| Device Name: | MONITOR, OXYCHEK OXYGEN |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | CRITIKON COMPANY,LLC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-20 |
| Decision Date | 1979-01-18 |