i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)— 510(k) K222727

Substantially Equivalent

I3 Membrane GmbH

FDA 510(k) clearance K222727 for i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S), Substantially Equivalent on 2023-06-02. Applicant: I3 Membrane GmbH.

Clearance details

Applicant: I3 Membrane GmbH
Product code: Code NHV
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-08
Decision date: 2023-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Radeberg, DE

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