Savvy口罩 - 第3級外科口罩
K 號：K213406 · 2021-11-18
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器材摘要
Savvy Mask - Level 3 Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medplast, LLC. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K213406. 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 Savvy Mask - Level 3 Surgical Face Mask?
Savvy Mask - Level 3 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Texas Medplast, LLC. The 510(k) number is K213406.
When did Savvy Mask - Level 3 Surgical Face Mask receive FDA 510(k) clearance?
Savvy Mask - Level 3 Surgical Face Mask received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213406.
Who is the listed applicant for Savvy Mask - Level 3 Surgical Face Mask?
The FDA 510(k) record lists Texas Medplast, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Savvy Mask - Level 3 Surgical Face Mask?
The FDA product code for Savvy Mask - Level 3 Surgical Face Mask is FXX.
相關臨床試驗
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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
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