The following data is part of a premarket notification filed by Myotronics-noromed, Inc. with the FDA for Model K7 Evaluation Device.
| Device ID | K003287 |
| 510k Number | K003287 |
| Device Name: | MODEL K7 EVALUATION DEVICE |
| Classification | Device, Muscle Monitoring |
| Applicant | MYOTRONICS-NOROMED, INC. 15425 53RD AVE. SOUTH Tukwila, WA 98188 |
| Contact | Fray Adib |
| Correspondent | Fray Adib MYOTRONICS-NOROMED, INC. 15425 53RD AVE. SOUTH Tukwila, WA 98188 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-20 |
| Decision Date | 2000-11-06 |