The following data is part of a premarket notification filed by Cadwell Industries, Inc. with the FDA for Cadwell Apollo System.
| Device ID | K180269 |
| 510k Number | K180269 |
| Device Name: | Cadwell Apollo System |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Cadwell Industries, Inc. 909 North Kellogg Street Kennewick, WA 99336 |
| Contact | Alison Hull |
| Correspondent | Alison Hull Cadwell Industries, Inc. 909 North Kellogg Street Kennewick, WA 99336 |
| Product Code | GWQ |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWL |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OLV |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-31 |
| Decision Date | 2018-07-17 |
| Summary: | summary |