呼吸識別 Hp 系統
K 號：K173772 · 2018-03-08
廣告
器材摘要
BreathID Hp System is the device name listed in this FDA 510(k) record. The listed applicant is Exalenz Bioscience , Ltd.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K173772. The device is classified under product code MSQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BreathID Hp System?
BreathID Hp System is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Exalenz Bioscience , Ltd.. The 510(k) number is K173772.
When did BreathID Hp System receive FDA 510(k) clearance?
BreathID Hp System received FDA 510(k) clearance on 2018-03-08, under 510(k) number K173772.
Who is the listed applicant for BreathID Hp System?
The FDA 510(k) record lists Exalenz Bioscience , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BreathID Hp System?
The FDA product code for BreathID Hp System is MSQ.
相關臨床試驗
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。
其他以 Exalenz Bioscience , Ltd. 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。
相關器械（代碼：MSQ）
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。
廣告