The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Kilowin.
| Device ID | K971214 |
| 510k Number | K971214 |
| Device Name: | KILOWIN |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Carlton Cadwell |
| Correspondent | Carlton Cadwell CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JXE |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-02 |
| Decision Date | 1998-06-11 |