FDA 510(k)

輪廓膝關節

K 號：K223429 · 2023-01-13

決定日期2023-01-13

產品代碼MOS

諮詢委員會RA

決定相當於

器材摘要

Contour Knee is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K223429. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Contour Knee?

Contour Knee is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Quality Electrodynamics, LLC. The 510(k) number is K223429.

When did Contour Knee receive FDA 510(k) clearance?

Contour Knee received FDA 510(k) clearance on 2023-01-13, under 510(k) number K223429.

Who is the listed applicant for Contour Knee?

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

What is the FDA product code for Contour Knee?

The FDA product code for Contour Knee is MOS.

其他以 Quality Electrodynamics, 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。

K242006SureWave 強度波攝影 (Q7000225)K200477Flex 身體加速器 K193140Flex Body 加速器 K183111輪廓24 K18169716ch 足/踝 SPEEDER K17346916ch T/R 手腕線圈

查看所有 14 項裝置 →

相關器械（代碼：MOS）

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。

K262330dS乳頭 7ch 1.5TdS乳頭 7ch 3.0TdS乳頭 16ch 1.5TdS乳頭 16ch 3.0TdS乳頭線圈 7ch 1.5TdS Sentinelle乳頭 16ch 1.5TdS Sentinelle乳頭 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS足踝16通道1.5T；dS足踝16通道3.0T；dS高解析手/腕16通道1.5T；dS高解析手/腕16CH 3.0T；dS小型 extremity 16通道1.5T；dS小型 extremity 16通道3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLC K252587HD 8通道手腕陣列Shenzhen RF Tech Co., Ltd.K252876GEM Flex 線圈 16-L 阵列，3.0T 接收僅；GEM Flex 線圈 16-M 阵列，3.0T 接收僅；GEM Flex 線圈 16-S 阵列，3.0T 接收僅Shenzhen RF Tech Co., Ltd.K260519Smart Fit 躯幹心臟 1.5TPhilips Healthcare (Suzhou) 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。