Gambro, Inc. · Class II · Cleared Jul 18, 1983
| K-number | K831677 |
| Device name | HYPER-HYPOTHERMIA UNIT HYPO 10-200 |
| Applicant | Gambro, Inc. |
| Product code | DWC |
| Device class | Class II |
| Decision date | Jul 18, 1983 |
| Decision | Substantially Equivalent |
| Regulation | 870.4250 |
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