The following data is part of a premarket notification filed by Alto Development Corp. with the FDA for Myo/clip.
| Device ID | K821518 |
| 510k Number | K821518 |
| Device Name: | MYO/CLIP |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | ALTO DEVELOPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-21 |
| Decision Date | 1982-07-08 |