K-number	K201135
Device name	Image1 S CCU, Image1 S 4U Camera Head
Applicant	KARL STORZ Endoscopy-America, Inc.
Product code	FET
Device class	Class II
Decision date	Sep 1, 2020
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Image1 S CCU, Image1 S 4U Camera Head

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