FDA 510(k)

單次使用耳環式外科口罩

K 號：K201691 · 2020-09-17

申請人Qiqihar Hengxin Medical Supplies, Ltd.

決定日期2020-09-17

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

Single-Use Surgical Mask With Ear Loop is the device name listed in this FDA 510(k) record. The listed applicant is Qiqihar Hengxin Medical Supplies, Ltd.. It received FDA 510(k) clearance on 2020-09-17 under 510(k) number K201691. 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 Single-Use Surgical Mask With Ear Loop?

Single-Use Surgical Mask With Ear Loop is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Qiqihar Hengxin Medical Supplies, Ltd.. The 510(k) number is K201691.

When did Single-Use Surgical Mask With Ear Loop receive FDA 510(k) clearance?

Single-Use Surgical Mask With Ear Loop received FDA 510(k) clearance on 2020-09-17, under 510(k) number K201691.

Who is the listed applicant for Single-Use Surgical Mask With Ear Loop?

The FDA 510(k) record lists Qiqihar Hengxin Medical Supplies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Surgical Mask With Ear Loop?

The FDA product code for Single-Use Surgical Mask With Ear Loop is FXX.

其他以 Qiqihar Hengxin Medical Supplies, Ltd. 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。

K201924單次使用外科口罩

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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