Name: Predicase
Price: 199 USD

K-number	K233321
Device name	Double Balloon Endoscope EN-840T, Over-tube TS-1214C
Applicant	FUJIFILM Healthcare Americas Corporation
Product code	FDA
Device class	Class II
Decision date	Jun 13, 2024
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Double Balloon Endoscope EN-840T, Over-tube TS-1214C

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