FDA 510(k)

巴克西爾準備式傷口灌洗器

K 號：K192349 · 2020-01-23

決定日期2020-01-23

產品代碼FQH

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Bactisure Wound Lavage is the device name listed in this FDA 510(k) record. The listed applicant is Next Science, LLC. It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K192349. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bactisure Wound Lavage?

Bactisure Wound Lavage is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Next Science, LLC. The 510(k) number is K192349.

When did Bactisure Wound Lavage receive FDA 510(k) clearance?

Bactisure Wound Lavage received FDA 510(k) clearance on 2020-01-23, under 510(k) number K192349.

Who is the listed applicant for Bactisure Wound Lavage?

The FDA 510(k) record lists Next Science, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bactisure Wound Lavage?

The FDA product code for Bactisure Wound Lavage is FQH.

其他以 Next Science, LLC 為申請人之記錄

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相關器械（代碼：FQH）

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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