Terumo Medical Corp. · Class II · Cleared May 6, 1997
| K-number | K970463 |
| Device name | CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR |
| Applicant | Terumo Medical Corp. |
| Product code | DTZ |
| Device class | Class II |
| Decision date | May 6, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
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