FDA 510(k)

PREMIUM - SHELTA 假肢零件

K 號：K162028 · 2017-03-24

決定日期2017-03-24

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

PREMIUM - SHELTA Prosthetic Components is the device name listed in this FDA 510(k) record. The listed applicant is Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162028. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PREMIUM - SHELTA Prosthetic Components?

PREMIUM - SHELTA Prosthetic Components is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K162028.

When did PREMIUM - SHELTA Prosthetic Components receive FDA 510(k) clearance?

PREMIUM - SHELTA Prosthetic Components received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162028.

Who is the listed applicant for PREMIUM - SHELTA Prosthetic Components?

The FDA 510(k) record lists Sweden & Martina S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMIUM - SHELTA Prosthetic Components?

The FDA product code for PREMIUM - SHELTA Prosthetic Components is NHA.

其他以 Sweden & Martina S.P.A. 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。

K222640瑞典 & Martina 医療器械監管文本瑞典 & Martina 外科器械架 K182084瑞典 & Martina 外科托盤（型號 ZSHORTY-INT）K180365PRAMA 白色植入系統 K161989預訂級植入系統 SHELTA 植入系統 K172560PREMIUM ONE 假體系統 K162004預訂級植入系統 SHELTA 植入系統

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相關器械（代碼：NHA）

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。

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官方來源

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