FDA 510(k)

瑞德恩 SW

K 號：K233625 · 2024-05-16

決定日期2024-05-16

產品代碼PNN

諮詢委員會DE

決定相當於

器材摘要

RAYDENT SW is the device name listed in this FDA 510(k) record. The listed applicant is Ray Co., Ltd.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K233625. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RAYDENT SW?

RAYDENT SW is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Ray Co., Ltd.. The 510(k) number is K233625.

When did RAYDENT SW receive FDA 510(k) clearance?

RAYDENT SW received FDA 510(k) clearance on 2024-05-16, under 510(k) number K233625.

Who is the listed applicant for RAYDENT SW?

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

What is the FDA product code for RAYDENT SW?

The FDA product code for RAYDENT SW is PNN.

其他以 Ray Co., Ltd. 為申請人之記錄

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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相關器械（代碼：PNN）

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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