The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Cardiac Pace. Opus 4000 Models 4043/4044/4063/4066.
| Device ID | K882427 |
| 510k Number | K882427 |
| Device Name: | CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 |
| 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 | 1988-06-13 |
| Decision Date | 1988-09-23 |