FDA 510(k)

Osstell 銀河灯塔

K 號：K181888 · 2019-08-22

決定日期2019-08-22

產品代碼EKX

諮詢委員會DE

決定相當於

器材摘要

Osstell Beacon is the device name listed in this FDA 510(k) record. The listed applicant is Osstell AB. It received FDA 510(k) clearance on 2019-08-22 under 510(k) number K181888. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Osstell Beacon?

Osstell Beacon is a medical device that received FDA 510(k) clearance on 2019-08-22. The listed applicant is Osstell AB. The 510(k) number is K181888.

When did Osstell Beacon receive FDA 510(k) clearance?

Osstell Beacon received FDA 510(k) clearance on 2019-08-22, under 510(k) number K181888.

Who is the listed applicant for Osstell Beacon?

FDA 510(k) 記錄將 Osstell AB 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Osstell Beacon?

The FDA product code for Osstell Beacon is EKX.

其他以 Osstell AB 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。

K261987可重用智慧釘

相關器械（代碼：EKX）

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。

K261987可重用智慧釘Osstell AB K252223Alpha Endo 手柄（Alpha Endo）SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597內視系統Perimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo 電機 (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

官方來源

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