The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for I-channel Recorder.
| Device ID | K833000 |
| 510k Number | K833000 |
| Device Name: | I-CHANNEL RECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | LITTON MEDICAL ELECTRONICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-18 |
| Decision Date | 1984-06-01 |