Name: Predicase
Price: 199 USD

K-number	K233225
Device name	SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
Applicant	Schoelly Fiberoptic GmbH
Product code	GCJ
Device class	Class II
Decision date	Jun 20, 2024
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

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