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FDA 510(k)

Aspire 通氣管

K 號:K182248 · 2018-11-13

決定日期2018-11-13
產品代碼KNT
諮詢委員會GU
決定相當於

器材摘要

Aspire Venting Tube is the device name listed in this FDA 510(k) record. The listed applicant is Aspire Bariatrics, Inc.. It received FDA 510(k) clearance on 2018-11-13 under 510(k) number K182248. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aspire Venting Tube?

Aspire Venting Tube is a medical device that received FDA 510(k) clearance on 2018-11-13. The listed applicant is Aspire Bariatrics, Inc.. The 510(k) number is K182248.

When did Aspire Venting Tube receive FDA 510(k) clearance?

Aspire Venting Tube received FDA 510(k) clearance on 2018-11-13, under 510(k) number K182248.

Who is the listed applicant for Aspire Venting Tube?

The FDA 510(k) record lists Aspire Bariatrics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aspire Venting Tube?

The FDA product code for Aspire Venting Tube is KNT.

相關臨床試驗

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其他以 Aspire Bariatrics, Inc. 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。

相關器械(代碼:KNT)

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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