FDA 510(k)

H-Max S stem

K 號：K160011 · 2016-08-22

決定日期2016-08-22

產品代碼MEH

諮詢委員會OR

決定Substantially Equivalent

器材摘要

H-Max S stem is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2016-08-22 under 510(k) number K160011. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the H-Max S stem?

H-Max S stem is a medical device that received FDA 510(k) clearance on 2016-08-22. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K160011.

When did H-Max S stem receive FDA 510(k) clearance?

H-Max S stem received FDA 510(k) clearance on 2016-08-22, under 510(k) number K160011.

Who is the listed applicant for H-Max S stem?

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

What is the FDA product code for H-Max S stem?

The FDA product code for H-Max S stem is MEH.

其他以 Lima Corporate S.P.A. 為申請人之記錄

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相關器械（代碼：MEH）

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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