FDA 510(k)

DUO1 和 DUO2

K 號：K241649 · 2024-07-05

決定日期2024-07-05

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

DUO1 and DUO2 is the device name listed in this FDA 510(k) record. The listed applicant is Zinnovi, Inc.. It received FDA 510(k) clearance on 2024-07-05 under 510(k) number K241649. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DUO1 and DUO2?

DUO1 and DUO2 is a medical device that received FDA 510(k) clearance on 2024-07-05. The listed applicant is Zinnovi, Inc.. The 510(k) number is K241649.

When did DUO1 and DUO2 receive FDA 510(k) clearance?

DUO1 and DUO2 received FDA 510(k) clearance on 2024-07-05, under 510(k) number K241649.

Who is the listed applicant for DUO1 and DUO2?

The FDA 510(k) record lists Zinnovi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUO1 and DUO2?

The FDA product code for DUO1 and DUO2 is MUH.

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官方來源

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