FDA 510(k)

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

K 號：K222727 · 2023-06-02

決定日期2023-06-02

產品代碼NHV

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：NHV）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：NHV）

官方來源