Ela Medical, Inc. · Class III · Cleared Sep 1, 1995
| K-number | K952364 |
| Device name | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) |
| Applicant | Ela Medical, Inc. |
| Product code | DXY |
| Device class | Class III |
| Decision date | Sep 1, 1995 |
| Decision | Substantially Equivalent - Subject to Tracking Reg. |
| Regulation | 870.3610 |
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