Class Class II

ONE-CUF (K230145)

K230145 2023-03-14 Traditional
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Description

ONE-CUF by Ge Medical Systems Information Technologies, Inc. — FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230145
Clearance Date2023-03-14
Clearance TypeTraditional
Product CodeDXQ
Regulation Number870.1120

Categories

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