The following data is part of a premarket notification filed by Motion Control, Inc. with the FDA for Myolab Ii, Model Ml-200.
| Device ID | K862236 |
| 510k Number | K862236 |
| Device Name: | MYOLAB II, MODEL ML-200 |
| Classification | Electromyograph, Diagnostic |
| Applicant | MOTION CONTROL, INC. 1005 SOUTH 300 WEST Salt Lake City, UT 84101 |
| Contact | Richard D Luntz |
| Correspondent | Richard D Luntz MOTION CONTROL, INC. 1005 SOUTH 300 WEST Salt Lake City, UT 84101 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-11 |
| Decision Date | 1986-08-07 |