The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Medical Multilith Pulse Genera-1140.
| Device ID | K813246 |
| 510k Number | K813246 |
| Device Name: | MEDICAL MULTILITH PULSE GENERA-1140 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | ELA MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-18 |
| Decision Date | 1982-02-12 |