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FDA 510(k)

雷射帽,型號:帽-01

K 號:K232356 · 2023-10-24

決定日期2023-10-24
產品代碼OAP
諮詢委員會PM
決定相當於

器材摘要

Laser Cap, Model: Hat-01 is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Yjt Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232356. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Laser Cap, Model: Hat-01?

Laser Cap, Model: Hat-01 is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Hubei Yjt Technology Co.,Ltd. The 510(k) number is K232356.

When did Laser Cap, Model: Hat-01 receive FDA 510(k) clearance?

Laser Cap, Model: Hat-01 received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232356.

Who is the listed applicant for Laser Cap, Model: Hat-01?

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

What is the FDA product code for Laser Cap, Model: Hat-01?

The FDA product code for Laser Cap, Model: Hat-01 is OAP.

相關臨床試驗

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其他以 Hubei Yjt Technology 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。

相關器械(代碼:OAP)

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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