FDA 510(k)

安全呼吸過濾口器

K 號：K190022 · 2019-09-25

決定日期2019-09-25

產品代碼CAH

諮詢委員會AN

決定相當於

器材摘要

SafeBreath Filter Mouthpiece is the device name listed in this FDA 510(k) record. The listed applicant is MD Diagnostics Limited. It received FDA 510(k) clearance on 2019-09-25 under 510(k) number K190022. 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 SafeBreath Filter Mouthpiece?

SafeBreath Filter Mouthpiece is a medical device that received FDA 510(k) clearance on 2019-09-25. The listed applicant is MD Diagnostics Limited. The 510(k) number is K190022.

When did SafeBreath Filter Mouthpiece receive FDA 510(k) clearance?

SafeBreath Filter Mouthpiece received FDA 510(k) clearance on 2019-09-25, under 510(k) number K190022.

Who is the listed applicant for SafeBreath Filter Mouthpiece?

The FDA 510(k) record lists MD Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeBreath Filter Mouthpiece?

The FDA product code for SafeBreath Filter Mouthpiece is CAH.

其他以 MD Diagnostics Limited 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。

K171129CO Check Pro, 一氧化碳檢測器 CO Screen, 一氧化碳檢測屏

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。

K252643Iso-Gard過濾直管；濕氣通風過濾器小型斜角Teleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® 呼氣過濾器Ambu A/S K241339貝美斯細菌過濾器和HMEFBesmed Health Business Corp K222917呼吸回路細菌/病毒過濾器Shaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir 氣管切開術病毒及細菌呼吸道保護過濾器 (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 角度呼吸過濾器（1545020）Intersurgical , Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。