Name: Predicase
Price: 199 USD

K-number	K221591
Device name	Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
Applicant	Schoelly Fiberoptic GmbH
Product code	GCJ
Device class	Class II
Decision date	Feb 23, 2023
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.