The following data is part of a premarket notification filed by Myotronics-noromed, Inc. with the FDA for Model Mes-9000/emg System.
| Device ID | K013399 |
| 510k Number | K013399 |
| Device Name: | MODEL MES-9000/EMG SYSTEM |
| 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 | 2001-10-15 |
| Decision Date | 2001-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D792N9600A0 | K013399 | 000 |
| D792N9200A0 | K013399 | 000 |
| D792N91500 | K013399 | 000 |
| D792N150MES0 | K013399 | 000 |
| D792N12013 | K013399 | 000 |