FDA 510(k)

BiWaze 咳嗽

K 號：K191912 · 2020-03-27

決定日期2020-03-27

產品代碼NHJ

諮詢委員會AN

決定相當於

器材摘要

BiWaze Cough is the device name listed in this FDA 510(k) record. The listed applicant is Abmrc, LLC. It received FDA 510(k) clearance on 2020-03-27 under 510(k) number K191912. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BiWaze Cough?

BiWaze Cough is a medical device that received FDA 510(k) clearance on 2020-03-27. The listed applicant is Abmrc, LLC. The 510(k) number is K191912.

When did BiWaze Cough receive FDA 510(k) clearance?

BiWaze Cough received FDA 510(k) clearance on 2020-03-27, under 510(k) number K191912.

Who is the listed applicant for BiWaze Cough?

FDA 510(k) 記錄中將 Abmrc, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for BiWaze Cough?

The FDA product code for BiWaze Cough is NHJ.

其他以 Abmrc, LLC 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。

K260604BiWaze 清潔系統 K231728BiWaze 清潔系統 K213564BiWaze 清潔系統

相關器械（代碼：NHJ）

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。

K260604BiWaze 清潔系統Abmrc, LLC K253001KT 氣道清除設備 II (KT-3)；KT 氣道清除設備 II (KT-5)Hunan Ruijiong Biotech Co., Ltd.K242438清朗Breas Medical AB K231728BiWaze 清潔系統Abmrc, LLC K213564BiWaze 清潔系統Abmrc, LLC K200988Maximus系統Hill-Rom Services Pte, Ltd.

官方來源

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