FDA 510(k)

GM501 精子氣和GM501 精子活

K 號：K192644 · 2020-04-23

決定日期2020-04-23

產品代碼MQL

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

GM501 SpermAir and GM501 SpermActive is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne Incorporated. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K192644. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GM501 SpermAir and GM501 SpermActive?

GM501 SpermAir and GM501 SpermActive is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Hamilton Thorne Incorporated. The 510(k) number is K192644.

When did GM501 SpermAir and GM501 SpermActive receive FDA 510(k) clearance?

GM501 SpermAir and GM501 SpermActive received FDA 510(k) clearance on 2020-04-23, under 510(k) number K192644.

Who is the listed applicant for GM501 SpermAir and GM501 SpermActive?

The FDA 510(k) record lists Hamilton Thorne Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GM501 SpermAir and GM501 SpermActive?

The FDA product code for GM501 SpermAir and GM501 SpermActive is MQL.

其他以 Hamilton Thorne Incorporated 為申請人之記錄

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K192503GM501 使用酚紅及壺菌素清潔

相關器械（代碼：MQL）

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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