| K-number | K132839 |
| Device name | FUSE 1C COLONOSCOPY SYSTEM |
| Applicant | Endochoice, Inc. |
| Product code | FDF |
| Device class | Class II |
| Decision date | Feb 6, 2014 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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