Planmed OY · Class II · Cleared May 24, 1995
| K-number | K951883 |
| Device name | PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT |
| Applicant | Planmed OY |
| Product code | IZH |
| Device class | Class II |
| Decision date | May 24, 1995 |
| Decision | Substantially Equivalent |
| Regulation | 892.1710 |
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