Class Class II

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source (K221591)

K221591 2023-02-23 Traditional
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Description

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source by Schoelly Fiberoptic GmbH — FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK221591
Clearance Date2023-02-23
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500

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