OCS
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
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| Record | Firm | Date |
|---|---|---|
| STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 (K100852) | Stryker Communications | 2010-05-06 |
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