Pentax of America, Inc. · Class II · Cleared Dec 30, 2020
| K-number | K203166 |
| Device name | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U |
| Applicant | Pentax of America, Inc. |
| Product code | ODG |
| Device class | Class II |
| Decision date | Dec 30, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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