K-number	K233200
Device name	XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
Applicant	GEMSS HEALTHCARE CO., LTD.
Product code	OWB
Device class	Class II
Decision date	Nov 16, 2023
Decision	Substantially Equivalent
Regulation	892.1650

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View the full FDA submission: accessdata.fda.gov

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XPLUS 35 Series (XPLUS 35, XPLUS 35FD)

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