A Breathing System (ABS)
K 號：K233580 · 2024-08-01
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器材摘要
A Breathing System (ABS) is the device name listed in this FDA 510(k) record. The listed applicant is Deepwell Dtx, Inc.. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K233580. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the A Breathing System (ABS)?
A Breathing System (ABS) is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Deepwell Dtx, Inc.. The 510(k) number is K233580.
When did A Breathing System (ABS) receive FDA 510(k) clearance?
A Breathing System (ABS) received FDA 510(k) clearance on 2024-08-01, under 510(k) number K233580.
Who is the listed applicant for A Breathing System (ABS)?
The FDA 510(k) record lists Deepwell Dtx, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for A Breathing System (ABS)?
The FDA product code for A Breathing System (ABS) is HCC.
相關臨床試驗
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相關器械（代碼：HCC）
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
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。
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