The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon Oxygen Monitor, Model 8030.
| Device ID | K821936 |
| 510k Number | K821936 |
| Device Name: | CRITIKON OXYGEN MONITOR, MODEL 8030 |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | CRITIKON COMPANY,LLC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-29 |
| Decision Date | 1982-08-16 |