Name: Predicase
Price: 199 USD

K-number	K210485
Device name	PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
Applicant	Pentax of America, Inc.
Product code	FDS
Device class	Class II
Decision date	May 13, 2021
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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PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)

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