K-number	K210710
Device name	PENTAX Medical Video Duedenoscope ED34-i10T2
Applicant	Pentax of America, Inc.
Product code	FDT
Device class	Class II
Decision date	Apr 9, 2021
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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PENTAX Medical Video Duedenoscope ED34-i10T2

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