The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Opus Model 4021, Vvi, 5mm Unipolar.
| Device ID | K900461 |
| 510k Number | K900461 |
| Device Name: | OPUS MODEL 4021, VVI, 5MM UNIPOLAR |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Contact | Paul Kohl |
| Correspondent | Paul Kohl 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 | 1990-01-31 |
| Decision Date | 1990-03-14 |