FDA 510(k)

Argon Handset

K 號：K191064 · 2019-06-12

決定日期2019-06-12

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Argon Handset is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K191064. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Argon Handset?

Argon Handset is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K191064.

When did Argon Handset receive FDA 510(k) clearance?

Argon Handset received FDA 510(k) clearance on 2019-06-12, under 510(k) number K191064.

Who is the listed applicant for Argon Handset?

The FDA 510(k) record lists New Deantronics Taiwan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Argon Handset?

The FDA product code for Argon Handset is GEI.

其他以 New Deantronics Taiwan , 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。

查看所有 12 項裝置 →

相關器械（代碼：GEI）

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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片，按鈕開關（0703-046-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，按鈕開關，大量非無菌（0703-046-102）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片， rocking 開關（0703-047-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，rocking 開關，大量非無菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 馬里蘭頰部血管黏合器/分離器，納米塗層Covidien, LLC K254185波坦茲·普瑞美Jeisys Medical Incorporated K262364艾利安恩尼格瑪雷射設備Ellian Corp K253859紅色專業版（Scarlet Pro）VIOL Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。