The following data is part of a premarket notification filed by Cadwell Industries, Inc. with the FDA for Cadwell Zenith System.
| Device ID | K181466 |
| 510k Number | K181466 |
| Device Name: | Cadwell Zenith System |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Cadwell Industries, Inc. 909 North Kellogg Street Kennewick, WA 99336 |
| Contact | Alison Hull |
| Correspondent | John Cadwell Cadwell Industries, Inc. 909 North Kellogg Street Kennewick, WA 99336 |
| Product Code | GWQ |
| Subsequent Product Code | ETN |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GYC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-04 |
| Decision Date | 2018-09-01 |
| Summary: | summary |