K-number	K253269
Device name	OEC One CFD
Applicant	Ge Hualun Medical Systems Co. , Ltd.
Product code	OXO
Device class	Class II
Decision date	Nov 26, 2025
Decision	Substantially Equivalent
Regulation	892.1650

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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OEC One CFD

Everything you need for a 510(k) submission. Nothing you don't.