FDA 510(k)

Lelo Hex 滑潤天然橡膠乳膠避孕套

K 號：K243421 · 2025-03-07

決定日期2025-03-07

產品代碼HIS

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

Lelo Hex Lubricated Natural Rubber Latex Condom is the device name listed in this FDA 510(k) record. The listed applicant is Lelo, Inc.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K243421. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lelo Hex Lubricated Natural Rubber Latex Condom?

Lelo Hex Lubricated Natural Rubber Latex Condom is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Lelo, Inc.. The 510(k) number is K243421.

When did Lelo Hex Lubricated Natural Rubber Latex Condom receive FDA 510(k) clearance?

Lelo Hex Lubricated Natural Rubber Latex Condom received FDA 510(k) clearance on 2025-03-07, under 510(k) number K243421.

Who is the listed applicant for Lelo Hex Lubricated Natural Rubber Latex Condom?

The FDA 510(k) record lists Lelo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lelo Hex Lubricated Natural Rubber Latex Condom?

The FDA product code for Lelo Hex Lubricated Natural Rubber Latex Condom is HIS.

其他以 Lelo, Inc. 為申請人之記錄

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K162511LELO 尊重 HEX 天然橡膠乳膠避孕套 K160644Lelo Hex 天然橡膠乳膠避孕套

相關器械（代碼：HIS）

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。

官方來源

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