The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Erg-jet Electrode.
| Device ID | K813399 |
| 510k Number | K813399 |
| Device Name: | ERG-JET ELECTRODE |
| Classification | Electrode, Corneal |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HLZ |
| CFR Regulation Number | 886.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-04 |
| Decision Date | 1982-01-22 |