The following data is part of a premarket notification filed by Myotronics-noromed, Inc. with the FDA for Norodyn 8000 Semg System, Nd-8000.
| Device ID | K992439 |
| 510k Number | K992439 |
| Device Name: | NORODYN 8000 SEMG SYSTEM, ND-8000 |
| Classification | Device, Biofeedback |
| 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 | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-22 |
| Decision Date | 1999-08-13 |
| Summary: | summary |