The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Opus Pacemakers (models 4001, 4003, 4004, 4023, 4024).
| Device ID | K952364 |
| 510k Number | K952364 |
| Device Name: | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Contact | Cathy Goble |
| Correspondent | Cathy Goble ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1995-09-01 |