The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell 5200.
| Device ID | K820031 |
| 510k Number | K820031 |
| Device Name: | CADWELL 5200 |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | CADWELL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-06 |
| Decision Date | 1982-02-04 |