The following data is part of a premarket notification filed by Myo-tronics Research, Inc. with the FDA for Model Em-ir.
| Device ID | K810528 |
| 510k Number | K810528 |
| Device Name: | MODEL EM-IR |
| Classification | Device, Muscle Monitoring |
| Applicant | MYO-TRONICS RESEARCH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-26 |
| Decision Date | 1981-03-31 |