Saneso, Inc. · Class II · Cleared Apr 1, 2022
| K-number | K210052 |
| Device name | Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)) |
| Applicant | Saneso, Inc. |
| Product code | FDF |
| Device class | Class II |
| Decision date | Apr 1, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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