The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Opus 3 Pulse Generators Models 4003,4004,4023,4024.
| Device ID | K882391 |
| 510k Number | K882391 |
| Device Name: | OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Contact | Tom S Anderson |
| Correspondent | Tom S Anderson ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-10 |
| Decision Date | 1988-11-14 |