FDA 510(k)

Schoelly 腹腔鏡/宮腔鏡及附件

K 號：K201970 · 2020-10-08

決定日期2020-10-08

產品代碼HIH

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Schoelly Cystoscopes/Hysteroscopes and Accessories 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 2020-10-08 under 510(k) number K201970. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Schoelly Cystoscopes/Hysteroscopes and Accessories?

Schoelly Cystoscopes/Hysteroscopes and Accessories is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K201970.

When did Schoelly Cystoscopes/Hysteroscopes and Accessories receive FDA 510(k) clearance?

Schoelly Cystoscopes/Hysteroscopes and Accessories received FDA 510(k) clearance on 2020-10-08, under 510(k) number K201970.

Who is the listed applicant for Schoelly Cystoscopes/Hysteroscopes and Accessories?

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 Cystoscopes/Hysteroscopes and Accessories?

The FDA product code for Schoelly Cystoscopes/Hysteroscopes and Accessories is HIH.

其他以 Schoelly Fiberoptic GmbH 為申請人之記錄

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相關器械（代碼：HIH）

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