| K-number | K970165 |
| Device name | EVITA 2 DURA |
| Applicant | Drager, Inc. |
| Product code | CBK |
| Device class | Class II |
| Decision date | Aug 26, 1997 |
| Decision | Substantially Equivalent - Subject to Tracking Reg. |
| Regulation | 868.5895 |
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