PGU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Spatial Imaging For Display Of Endoscope Position
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- To detect and display the shape of an inserted endoscope.
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| Record | Firm | Date |
|---|---|---|
| ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT (K134026) | Olympus Medical Systems Corp. | 2014-03-07 |
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