The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Opus S Model 4121 And 4124 Pacemakers.
| Device ID | K970072 |
| 510k Number | K970072 |
| Device Name: | OPUS S MODEL 4121 AND 4124 PACEMAKERS |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | ELA MEDICAL, INC. 2950 XENIUM LN. NORTH Plymouth, MN 55441 |
| Contact | Catherine G Goble |
| Correspondent | Catherine G Goble ELA MEDICAL, INC. 2950 XENIUM LN. NORTH Plymouth, MN 55441 |
| 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 | 1997-01-08 |
| Decision Date | 1997-08-29 |
| Summary: | summary |