K-number	K202365
Device name	Pentax Medical Video Duodenoscope ED32-i10
Applicant	Pentax of America, Inc.
Product code	FDT
Device class	Class II
Decision date	Apr 1, 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 Duodenoscope ED32-i10

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