The following data is part of a premarket notification filed by Cadwell Industries, Inc. with the FDA for Cadwell Sierra Summit, Cadwell Sierra Ascent.
| Device ID | K162383 |
| 510k Number | K162383 |
| Device Name: | Cadwell Sierra Summit, Cadwell Sierra Ascent |
| Classification | Electromyograph, Diagnostic |
| Applicant | CADWELL INDUSTRIES, INC. 909 NORTH KELLOGG STREET Kennewick, WA 99336 |
| Contact | Christopher Bolkan |
| Correspondent | Christopher Bolkan CADWELL INDUSTRIES, INC. 909 NORTH KELLOGG STREET Kennewick, WA 99336 |
| Product Code | IKN |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GZP |
| Subsequent Product Code | JXE |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-25 |
| Decision Date | 2017-03-01 |
| Summary: | summary |