3 層手術口罩 (134252531)
K 號：K231618 · 2023-07-28
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器材摘要
3 Layer Surgical Mask (134252531) is the device name listed in this FDA 510(k) record. The listed applicant is Original Mattress Factory, Inc.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K231618. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the 3 Layer Surgical Mask (134252531)?
3 Layer Surgical Mask (134252531) is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Original Mattress Factory, Inc.. The 510(k) number is K231618.
When did 3 Layer Surgical Mask (134252531) receive FDA 510(k) clearance?
3 Layer Surgical Mask (134252531) received FDA 510(k) clearance on 2023-07-28, under 510(k) number K231618.
Who is the listed applicant for 3 Layer Surgical Mask (134252531)?
The FDA 510(k) record lists Original Mattress Factory, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 3 Layer Surgical Mask (134252531)?
The FDA product code for 3 Layer Surgical Mask (134252531) is FXX.
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相關器械（代碼：FXX）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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