K-number	K221642
Device name	SIRIUS Endoscope System
Applicant	Precision Robotics (Hong Kong) Limited
Product code	HET
Device class	Class II
Decision date	Dec 12, 2022
Decision	Substantially Equivalent
Regulation	884.1720

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Source

View the full FDA submission: accessdata.fda.gov

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SIRIUS Endoscope System

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