Bio-Detek, Inc. · Class III · Cleared Nov 16, 2010
| K-number | K100565 |
| Device name | DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 |
| Applicant | Bio-Detek, Inc. |
| Product code | MKJ |
| Device class | Class III |
| Decision date | Nov 16, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 870.5310 |
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