FDA 510(k)

POSE™醫療保健外科口罩

K 號：K223270 · 2022-11-01

決定日期2022-11-01

產品代碼FXX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

POSE™ Health Care Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is America'S Supply Chains. It received FDA 510(k) clearance on 2022-11-01 under 510(k) number K223270. 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 POSE™ Health Care Surgical Mask?

POSE™ Health Care Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-11-01. The listed applicant is America'S Supply Chains. The 510(k) number is K223270.

When did POSE™ Health Care Surgical Mask receive FDA 510(k) clearance?

POSE™ Health Care Surgical Mask received FDA 510(k) clearance on 2022-11-01, under 510(k) number K223270.

Who is the listed applicant for POSE™ Health Care Surgical Mask?

The FDA 510(k) record lists America'S Supply Chains as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POSE™ Health Care Surgical Mask?

The FDA product code for POSE™ Health Care Surgical Mask is FXX.

其他以 America'S Supply Chains 為申請人之記錄

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。

K222749高濾水性外科手術及程序口罩

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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