The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Multilith 2 Pulse Generator 1141 & 2141.
| Device ID | K842220 |
| 510k Number | K842220 |
| Device Name: | MULTILITH 2 PULSE GENERATOR 1141 & 2141 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | ELA MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Contact | Tom Anderson |
| Correspondent | Tom Anderson ELA MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-05 |
| Decision Date | 1984-11-29 |