FDA 510(k)

EPINAUT

K 號：K173541 · 2018-08-24

決定日期2018-08-24

產品代碼BSO

諮詢委員會AN

決定相當於

器材摘要

EPINAUT 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 2018-08-24 under 510(k) number K173541. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EPINAUT?

EPINAUT is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Imedicom Co., Ltd.. The 510(k) number is K173541.

When did EPINAUT receive FDA 510(k) clearance?

EPINAUT received FDA 510(k) clearance on 2018-08-24, under 510(k) number K173541.

Who is the listed applicant for EPINAUT?

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 EPINAUT?

The FDA product code for EPINAUT is BSO.

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 K153296MEDINAUT脊椎成形系統 K150915SPINAUT-P K151268SPINAUT-V, SPINAUT-S, SPINAUT-I K150789SPINAUT-E, SPINAUT-I

相關器械（代碼：BSO）

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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