The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Model 8400 W/modifications (spectrum 32).
| Device ID | K860801 |
| 510k Number | K860801 |
| Device Name: | MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Calton M Cadwell |
| Correspondent | Calton M Cadwell CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-11-18 |