The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon Dual Channel Recorder.
| Device ID | K792105 |
| 510k Number | K792105 |
| Device Name: | CRITIKON DUAL CHANNEL RECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | CRITIKON COMPANY,LLC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-22 |
| Decision Date | 1979-10-26 |