FDA 510(k)

壓力雙聯精英型，壓力雙聯精英型 AG

K 號：K173450 · 2018-02-07

決定日期2018-02-07

產品代碼DXT

諮詢委員會履歷

決定相當於

器材摘要

PRESS DUO elite, PRESS DUO elite AG is the device name listed in this FDA 510(k) record. The listed applicant is Nemoto Kyorindo Co., Ltd.. It received FDA 510(k) clearance on 2018-02-07 under 510(k) number K173450. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PRESS DUO elite, PRESS DUO elite AG?

PRESS DUO elite, PRESS DUO elite AG is a medical device that received FDA 510(k) clearance on 2018-02-07. The listed applicant is Nemoto Kyorindo Co., Ltd.. The 510(k) number is K173450.

When did PRESS DUO elite, PRESS DUO elite AG receive FDA 510(k) clearance?

PRESS DUO elite, PRESS DUO elite AG received FDA 510(k) clearance on 2018-02-07, under 510(k) number K173450.

Who is the listed applicant for PRESS DUO elite, PRESS DUO elite AG?

The FDA 510(k) record lists Nemoto Kyorindo Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESS DUO elite, PRESS DUO elite AG?

The FDA product code for PRESS DUO elite, PRESS DUO elite AG is DXT.

其他以 Nemoto Kyorindo Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K242212一次性針筒（套組）；內藤一次性針筒（套組）

相關器械（代碼：DXT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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