EchoMD 自動射血分數軟體
K 號：K173780 · 2018-06-14
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器材摘要
EchoMD Automated Ejection Fraction Software is the device name listed in this FDA 510(k) record. The listed applicant is Bay Labs, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K173780. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EchoMD Automated Ejection Fraction Software?
EchoMD Automated Ejection Fraction Software is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Bay Labs, Inc.. The 510(k) number is K173780.
When did EchoMD Automated Ejection Fraction Software receive FDA 510(k) clearance?
EchoMD Automated Ejection Fraction Software received FDA 510(k) clearance on 2018-06-14, under 510(k) number K173780.
Who is the listed applicant for EchoMD Automated Ejection Fraction Software?
The FDA 510(k) record lists Bay Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EchoMD Automated Ejection Fraction Software?
The FDA product code for EchoMD Automated Ejection Fraction Software is LLZ.
相關臨床試驗
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相關器械（代碼：LLZ）
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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