i3 ONE (203100-S); i3 TWO connect (203200-S); i3 TWO direct (203300-S)— 510(k) K222727
Substantially EquivalentI3 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. Device class: 2.
Clearance details
- Device name as filed
- i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
- Applicant
- I3 Membrane GmbH
- Product code
- Code NHV
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Radeberg, DE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.