FDA 510(k)

單端口

K 號：K232062 · 2024-01-16

決定日期2024-01-16

產品代碼OTJ

諮詢委員會GU

決定相當於

器材摘要

Uni-port is the device name listed in this FDA 510(k) record. The listed applicant is Dalim Medical Corp.. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K232062. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Uni-port?

Uni-port is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Dalim Medical Corp.. The 510(k) number is K232062.

When did Uni-port receive FDA 510(k) clearance?

Uni-port received FDA 510(k) clearance on 2024-01-16, under 510(k) number K232062.

Who is the listed applicant for Uni-port?

The FDA 510(k) record lists Dalim Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uni-port?

The FDA product code for Uni-port is OTJ.

相關器械（代碼：OTJ）

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官方來源

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