FDA 510(k)

SPINAUT-V, SPINAUT-S, SPINAUT-I

K 號：K151268 · 2016-03-16

決定日期2016-03-16

產品代碼HRX

諮詢委員會或

決定相當於

器材摘要

SPINAUT-V, SPINAUT-S, SPINAUT-I 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 2016-03-16 under 510(k) number K151268. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPINAUT-V, SPINAUT-S, SPINAUT-I?

SPINAUT-V, SPINAUT-S, SPINAUT-I is a medical device that received FDA 510(k) clearance on 2016-03-16. The listed applicant is Imedicom Co., Ltd.. The 510(k) number is K151268.

When did SPINAUT-V, SPINAUT-S, SPINAUT-I receive FDA 510(k) clearance?

SPINAUT-V, SPINAUT-S, SPINAUT-I received FDA 510(k) clearance on 2016-03-16, under 510(k) number K151268.

Who is the listed applicant for SPINAUT-V, SPINAUT-S, SPINAUT-I?

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-V, SPINAUT-S, SPINAUT-I?

The FDA product code for SPINAUT-V, SPINAUT-S, SPINAUT-I is HRX.

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。

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相關器械（代碼：HRX）

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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