FDA 510(k)

HPR無線衛生手柄

K 號：K243911 · 2024-12-20

決定日期2024-12-20

產品代碼EKX

諮詢委員會DE

決定相當於

器材摘要

HPR Cordless Hygiene Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Handpiece Headquarters. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K243911. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HPR Cordless Hygiene Handpiece?

HPR Cordless Hygiene Handpiece is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Handpiece Headquarters. The 510(k) number is K243911.

When did HPR Cordless Hygiene Handpiece receive FDA 510(k) clearance?

HPR Cordless Hygiene Handpiece received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243911.

Who is the listed applicant for HPR Cordless Hygiene Handpiece?

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

What is the FDA product code for HPR Cordless Hygiene Handpiece?

The FDA product code for HPR Cordless Hygiene Handpiece is EKX.

其他以 Handpiece Headquarters 為申請人之記錄

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相關器械（代碼：EKX）

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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