K-number	K213235
Device name	PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
Applicant	Pentax of America, Inc.
Product code	EOQ
Device class	Class II
Decision date	Dec 21, 2022
Decision	Substantially Equivalent
Regulation	874.4680

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View the full FDA submission: accessdata.fda.gov

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PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System

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