FDA 510(k)

獨立智能注射針筒適配器（獨立智能®）

K 號：K231820 · 2024-01-12

決定日期2024-01-12

產品代碼QOG

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

SoloSmart Injection Pen Adapter (SoloSmart®) is the device name listed in this FDA 510(k) record. The listed applicant is Biocorp Production. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K231820. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SoloSmart Injection Pen Adapter (SoloSmart®)?

SoloSmart Injection Pen Adapter (SoloSmart®) is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Biocorp Production. The 510(k) number is K231820.

When did SoloSmart Injection Pen Adapter (SoloSmart®) receive FDA 510(k) clearance?

SoloSmart Injection Pen Adapter (SoloSmart®) received FDA 510(k) clearance on 2024-01-12, under 510(k) number K231820.

Who is the listed applicant for SoloSmart Injection Pen Adapter (SoloSmart®)?

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

What is the FDA product code for SoloSmart Injection Pen Adapter (SoloSmart®)?

The FDA product code for SoloSmart Injection Pen Adapter (SoloSmart®) is QOG.

其他以 Biocorp Production 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。

K251500MallyaG 注射針筒適配器（MallyaG）K250555MallyaD 注射針筒適用器（MallyaD）K222689Mallya 注射針筒適配器（Mallya® 用於 Solostar®）

相關器械（代碼：QOG）

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。

K243901SmartPilot YpsoMate NS-A2.25Ypsomed AG K251500MallyaG 注射針筒適配器（MallyaG）Biocorp Production K250555MallyaD 注射針筒適用器（MallyaD）Biocorp Production K241803INSULCLOCK® v2.0 PROInsulcloud S.L.K222689Mallya 注射針筒適配器（Mallya® 用於 Solostar®）Biocorp Production K212217時鐘智慧按鈕Eli Lilly and Company

官方來源

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