FDA 510(k)

Schoelly腎鏡組合，Schoelly超迷你腎鏡組合

K 號：K151308 · 2016-02-09

決定日期2016-02-09

產品代碼FGA

諮詢委員會GU

決定相當於

器材摘要

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K151308. The device is classified under product code FGA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set?

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K151308.

When did Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set receive FDA 510(k) clearance?

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set received FDA 510(k) clearance on 2016-02-09, under 510(k) number K151308.

Who is the listed applicant for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set?

The FDA 510(k) record lists Schoelly Fiberoptic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set?

The FDA product code for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set is FGA.

其他以 Schoelly Fiberoptic GmbH 為申請人之記錄

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相關器械（代碼：FGA）

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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