| K-number | K141286 |
| Device name | AER-O-SCOPE COLONOSCOPE SYSTEM |
| Applicant | Gi View , Ltd. |
| Product code | FDF |
| Device class | Class II |
| Decision date | Sep 30, 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