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FDA 510(k)

魏鼻噴管

K 號:K211543 · 2022-07-21

決定日期2022-07-21
產品代碼BTR
諮詢委員會AN
決定相當於

器材摘要

Wei Nasal Jet Tube is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-07-21 under 510(k) number K211543. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wei Nasal Jet Tube?

Wei Nasal Jet Tube is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K211543.

When did Wei Nasal Jet Tube receive FDA 510(k) clearance?

Wei Nasal Jet Tube received FDA 510(k) clearance on 2022-07-21, under 510(k) number K211543.

Who is the listed applicant for Wei Nasal Jet Tube?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wei Nasal Jet Tube?

The FDA product code for Wei Nasal Jet Tube is BTR.

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其他以 Well Lead Medical Co., Ltd. 為申請人之記錄

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相關器械(代碼:BTR)

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。

官方來源

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