Name: Predicase
Price: 199 USD

K-number	K230800
Device name	XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
Applicant	GEMSS HEALTHCARE CO., LTD.
Product code	KPR
Device class	Class II
Decision date	Nov 2, 2023
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50

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