| K-number | K945467 |
| Device name | BABYTHERM 8000 WB |
| Applicant | Drager, Inc. |
| Product code | ILO |
| Device class | Class II |
| Decision date | Apr 28, 1995 |
| Decision | Substantially Equivalent |
| Regulation | 890.5720 |
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