Class Class II

OEC One CFD (K253269)

K253269 2025-11-26 Traditional
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Description

OEC One CFD by Ge Hualun Medical Systems Co. , Ltd., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253269
Clearance Date2025-11-26
Clearance TypeTraditional
Product CodeOXO
Regulation Number892.1650

Categories

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