The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Pulse Generator Model 61 And 128.
| Device ID | K790562 |
| 510k Number | K790562 |
| Device Name: | PULSE GENERATOR MODEL 61 AND 128 |
| 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 | 1979-03-19 |
| Decision Date | 1979-05-08 |