FDA 510(k)

外科袍（無菌），外科袍（非无菌）

K 號：K202706 · 2020-12-31

申請人B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

決定日期2020-12-31

產品代碼FYA

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

Surgical Gown (Sterile), Surgical Gown (Non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. It received FDA 510(k) clearance on 2020-12-31 under 510(k) number K202706. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgical Gown (Sterile), Surgical Gown (Non-sterile)?

Surgical Gown (Sterile), Surgical Gown (Non-sterile) is a medical device that received FDA 510(k) clearance on 2020-12-31. The listed applicant is B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. The 510(k) number is K202706.

When did Surgical Gown (Sterile), Surgical Gown (Non-sterile) receive FDA 510(k) clearance?

Surgical Gown (Sterile), Surgical Gown (Non-sterile) received FDA 510(k) clearance on 2020-12-31, under 510(k) number K202706.

Who is the listed applicant for Surgical Gown (Sterile), Surgical Gown (Non-sterile)?

The FDA 510(k) record lists B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Gown (Sterile), Surgical Gown (Non-sterile)?

The FDA product code for Surgical Gown (Sterile), Surgical Gown (Non-sterile) is FYA.

其他以 B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. 為申請人之記錄

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K202843外科口罩（無菌），外科口罩（非无菌）

相關器械（代碼：FYA）

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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