Name: Predicase
Price: 199 USD

K-number	K200542
Device name	Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
Applicant	Olympus Medical Systems Corp.
Product code	OWN
Device class	Class II
Decision date	Jul 17, 2020
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head

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