The following data is part of a premarket notification filed by Myo-tronics, Inc. with the FDA for K6-1 Diagnostic System Version 3.1.
| Device ID | K944134 |
| 510k Number | K944134 |
| Device Name: | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 |
| Classification | Device, Muscle Monitoring |
| Applicant | MYO-TRONICS, INC. 15425 - 33RD AVENUE SOUTH Tukwila, WA 98188 |
| Contact | Fray Adib |
| Correspondent | Fray Adib MYO-TRONICS, INC. 15425 - 33RD AVENUE SOUTH Tukwila, WA 98188 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-24 |
| Decision Date | 1994-12-09 |