FDA 510(k)

ReddyPort 肘關節

K 號：K231064 · 2023-07-13

決定日期2023-07-13

產品代碼MNS

諮詢委員會AN

決定相當於

器材摘要

ReddyPort Elbow is the device name listed in this FDA 510(k) record. The listed applicant is Smd Manufacturing, LLC. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K231064. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the ReddyPort Elbow?

ReddyPort Elbow is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Smd Manufacturing, LLC. The 510(k) number is K231064.

When did ReddyPort Elbow receive FDA 510(k) clearance?

ReddyPort Elbow received FDA 510(k) clearance on 2023-07-13, under 510(k) number K231064.

Who is the listed applicant for ReddyPort Elbow?

The FDA 510(k) record lists Smd Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReddyPort Elbow?

The FDA product code for ReddyPort Elbow is MNS. This falls under the Neurology category.

其他以 Smd Manufacturing, LLC 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。

K171827ReddyPort NIV 接入口肘

相關器械（代碼：MNS）

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。

K251889我的空氣Resmed Corp K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661瑪麗安娜·米涅瓦；瑪麗安娜·尼布斯Resmed Pty , Ltd.K240778Vivo 1, Vivo 2Breas Medical AB K213169BPAP系統BMC Medical Co., Ltd.K171827ReddyPort NIV 接入口肘Smd Manufacturing, LLC

官方來源

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