FDA 510(k)

Insupen 静脈針，Insupen 原版針筒針，Insupen 高級針筒針

K 號：K203792 · 2023-01-20

決定日期2023-01-20

產品代碼FMI

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

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is the device name listed in this FDA 510(k) record. The listed applicant is Pikdare Spa. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K203792. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Pikdare Spa. The 510(k) number is K203792.

When did Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle receive FDA 510(k) clearance?

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle received FDA 510(k) clearance on 2023-01-20, under 510(k) number K203792.

Who is the listed applicant for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

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

What is the FDA product code for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

The FDA product code for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is FMI.

其他以 Pikdare Spa 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。

K223353DropSafe™ Sicura™

相關器械（代碼：FMI）

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。

K261266MOWANA™ 自動雙用式醫療設備PENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety 靜脈針Promisemed Hangzhou Meditech Co., Ltd.K262427針筒針（普通型I類，安全型IIA，安全型IIB，安全型IIIA，安全型IIIB，安全型IV，安全型V，普通型VIA，普通型VIB，普通型VIC，安全型VII，普通型IB，安全型VIII，安全型IX，安全型X，普通型XI，安全型XII）Hh Global Technology, Inc.K260933安全性無菌皮下針筒（NR-S1816R、NR-S1916R、NR-S1925R、NR-S1938R、NR-S2016R、NR-S2025R、NR-S2038R、NR-S2051R、NR-S2116R、NR-S2125R、NR-S2138R、NR-S2151R、NR-S2216R、NR-S2225R、NR-S2238R、NR-S2251R、NR-S2316R、NR-S2325R、NR-S2338R、NR-S2351R、NR-S2516R、NR-S2525R、NR-S2538R、NR-S2551R、NR-S2516T、NR-S2525T、NR-S2538T、NR-S2551T）Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™雙安全針筒CMT Health PTE., Ltd.K260739Profoject™ 靜脈針（型號A；型號B）CMT Health PTE., Ltd.

官方來源

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