Name: Predicase
Price: 199 USD

K-number	K223827
Device name	FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
Applicant	Fujifilm Corporation
Product code	FDF
Device class	Class II
Decision date	Sep 8, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01

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