FDA 510(k)

SPINAUT-P

K 號：K150915 · 2016-03-18

決定日期2016-03-18

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

SPINAUT-P is the device name listed in this FDA 510(k) record. The listed applicant is Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K150915. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPINAUT-P?

SPINAUT-P is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Imedicom Co., Ltd.. The 510(k) number is K150915.

When did SPINAUT-P receive FDA 510(k) clearance?

SPINAUT-P received FDA 510(k) clearance on 2016-03-18, under 510(k) number K150915.

Who is the listed applicant for SPINAUT-P?

The FDA 510(k) record lists Imedicom Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINAUT-P?

The FDA product code for SPINAUT-P is GEI.

其他以 Imedicom Co., Ltd. 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。

K182287MEDINAUT Plus K173541EPINAUT K153296MEDINAUT脊椎成形系統 K151268SPINAUT-V, SPINAUT-S, SPINAUT-I K150789SPINAUT-E, SPINAUT-I

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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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