Class Class II

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) (K222727)

K222727 2023-06-02 Traditional
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Description

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) by I3 Membrane GmbH — FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222727
Clearance Date2023-06-02
Clearance TypeTraditional
Product CodeNHV
Regulation Number876.5665

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