FDA 510(k)

Grosz 加熱液，Grosz 撲膩刺痛，Grosz KY 這邊是你的，那邊是我的

K 號：K213892 · 2023-03-07

決定日期2023-03-07

產品代碼NUC

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

Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine is the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us), LLC. It received FDA 510(k) clearance on 2023-03-07 under 510(k) number K213892. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine?

Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine is a medical device that received FDA 510(k) clearance on 2023-03-07. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K213892.

When did Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine receive FDA 510(k) clearance?

Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine received FDA 510(k) clearance on 2023-03-07, under 510(k) number K213892.

Who is the listed applicant for Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine?

The FDA 510(k) record lists Rb Health (Us), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine?

The FDA product code for Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine is NUC.

其他以 Rb Health (Us), LLC 為申請人之記錄

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相關器械（代碼：NUC）

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官方來源

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