| K-number | K053435 |
| Device name | GE VOLUSON I |
| Applicant | General Electric Co. |
| Product code | IYN |
| Device class | Class II |
| Decision date | Dec 16, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
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