Scimed Life Systems, Inc. · Class II · Cleared Sep 21, 1989
| K-number | K894103 |
| Device name | SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II |
| Applicant | Scimed Life Systems, Inc. |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Sep 21, 1989 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov