The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell 8400.
| Device ID | K830771 |
| 510k Number | K830771 |
| Device Name: | CADWELL 8400 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | CADWELL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWF |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWK |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-11 |
| Decision Date | 1983-04-12 |