K-number	K192280
Device name	PENTAX Medical ED-3490TK Video Duodenoscope
Applicant	Pentax Medical
Product code	FDT
Device class	Class II
Decision date	Oct 21, 2019
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 ED-3490TK Video Duodenoscope

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