The following data is part of a premarket notification filed by Mycron Medical, Inc. with the FDA for Myo-metric Ii.
| Device ID | K811312 |
| 510k Number | K811312 |
| Device Name: | MYO-METRIC II |
| Classification | Dynamometer, Ac-powered |
| Applicant | MYCRON MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBB |
| CFR Regulation Number | 888.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-11 |
| Decision Date | 1981-06-09 |