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FDA 510(k)

HepaShield細菌病毒呼吸系統過濾器

K 號:K191909 · 2020-03-23

決定日期2020-03-23
產品代碼CAH
諮詢委員會AN
決定相當於

器材摘要

HepaShield Bacterial Viral Breathing System Filter is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical Limited.. It received FDA 510(k) clearance on 2020-03-23 under 510(k) number K191909. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HepaShield Bacterial Viral Breathing System Filter?

HepaShield Bacterial Viral Breathing System Filter is a medical device that received FDA 510(k) clearance on 2020-03-23. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K191909.

When did HepaShield Bacterial Viral Breathing System Filter receive FDA 510(k) clearance?

HepaShield Bacterial Viral Breathing System Filter received FDA 510(k) clearance on 2020-03-23, under 510(k) number K191909.

Who is the listed applicant for HepaShield Bacterial Viral Breathing System Filter?

FDA 510(k) 記錄將 Flexicare Medical Limited. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for HepaShield Bacterial Viral Breathing System Filter?

The FDA product code for HepaShield Bacterial Viral Breathing System Filter is CAH.

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其他以 Flexicare Medical Limited. 為申請人之記錄

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相關器械(代碼:CAH)

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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