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FDA 510(k)

HD 8通道手腕陣列

K 號:K252587 · 2026-04-14

決定日期2026-04-14
產品代碼MOS
諮詢委員會RA
決定相當於

器材摘要

HD 8Ch Wrist Array is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen RF Tech Co., Ltd.. It received FDA 510(k) clearance on 2026-04-14 under 510(k) number K252587. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HD 8Ch Wrist Array?

HD 8Ch Wrist Array is a medical device that received FDA 510(k) clearance on 2026-04-14. The listed applicant is Shenzhen RF Tech Co., Ltd.. The 510(k) number is K252587.

When did HD 8Ch Wrist Array receive FDA 510(k) clearance?

HD 8Ch Wrist Array received FDA 510(k) clearance on 2026-04-14, under 510(k) number K252587.

Who is the listed applicant for HD 8Ch Wrist Array?

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

What is the FDA product code for HD 8Ch Wrist Array?

The FDA product code for HD 8Ch Wrist Array is MOS.

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其他以 Shenzhen RF Tech Co., Ltd. 為申請人之記錄

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相關器械(代碼:MOS)

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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