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FDA 510(k)

AquaCast 面罩

K 號:K252174 · 2025-09-03

決定日期2025-09-03
產品代碼IYE
諮詢委員會RA
決定相當於

器材摘要

AquaCast Mask is the device name listed in this FDA 510(k) record. The listed applicant is Blessing Cathay Corporation. It received FDA 510(k) clearance on 2025-09-03 under 510(k) number K252174. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AquaCast Mask?

AquaCast Mask is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Blessing Cathay Corporation. The 510(k) number is K252174.

When did AquaCast Mask receive FDA 510(k) clearance?

AquaCast Mask received FDA 510(k) clearance on 2025-09-03, under 510(k) number K252174.

Who is the listed applicant for AquaCast Mask?

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

What is the FDA product code for AquaCast Mask?

The FDA product code for AquaCast Mask is IYE.

相關臨床試驗

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相關器械(代碼:IYE)

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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