Name: Predicase
Price: 199 USD

K-number	K223926
Device name	VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
Applicant	Medimaging Integrated Solution, Inc (Miis)
Product code	FAJ
Device class	Class II
Decision date	Oct 6, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

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