| K-number | K971198 |
| Device name | BABYTHERM 8004 BABYTHERM 8010 |
| Applicant | Drager, Inc. |
| Product code | FMT |
| Device class | Class II |
| Decision date | Oct 3, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 880.5130 |
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