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FDA 510(k)

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

K-Number: K222727 · 2023-06-02

ApplicantI3 Membrane GmbH
Decision Date2023-06-02
Product CodeNHV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) is the device name listed in this FDA 510(k) record. The listed applicant is I3 Membrane GmbH. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K222727. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)?

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is I3 Membrane GmbH. The 510(k) number is K222727.

When did i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) receive FDA 510(k) clearance?

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) received FDA 510(k) clearance on 2023-06-02, under 510(k) number K222727.

Who is the listed applicant for i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)?

The FDA 510(k) record lists I3 Membrane GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)?

The FDA product code for i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) is NHV.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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