| K-number | K914109 |
| Device name | PIKOS 01 & PIKOS E 01 |
| Applicant | Biotronik, GmbH & Co. |
| Product code | DXY |
| Device class | Class III |
| Decision date | Feb 26, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 870.3610 |
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