The following data is part of a premarket notification filed by Myo-tronics, Inc. with the FDA for Ms-100 Myo-scanner Or Ms-100 Emg Scanner.
| Device ID | K921919 |
| 510k Number | K921919 |
| Device Name: | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER |
| Classification | Device, Muscle Monitoring |
| Applicant | MYO-TRONICS, INC. 720 OLIVE WAY SUITE 800 Seattle, WA 98101 |
| Contact | Adib |
| Correspondent | Adib MYO-TRONICS, INC. 720 OLIVE WAY SUITE 800 Seattle, WA 98101 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-23 |
| Decision Date | 1993-01-07 |