The following data is part of a premarket notification filed by Myotronics-noromed, Inc. with the FDA for Model J-5 Mvo-monitor.
| Device ID | K031998 |
| 510k Number | K031998 |
| Device Name: | MODEL J-5 MVO-MONITOR |
| Classification | Stimulator, Muscle, Powered, Dental |
| 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 | NUW |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-27 |
| Decision Date | 2003-07-24 |
| Summary: | summary |