eCordum 心臟監護器（eCordum CM）
K 號：K193296 · 2020-10-30
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器材摘要
eCordum Cardiac Monitor (eCordum CM) is the device name listed in this FDA 510(k) record. The listed applicant is Ecordum, Inc.. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K193296. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the eCordum Cardiac Monitor (eCordum CM)?
eCordum Cardiac Monitor (eCordum CM) is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Ecordum, Inc.. The 510(k) number is K193296.
When did eCordum Cardiac Monitor (eCordum CM) receive FDA 510(k) clearance?
eCordum Cardiac Monitor (eCordum CM) received FDA 510(k) clearance on 2020-10-30, under 510(k) number K193296.
Who is the listed applicant for eCordum Cardiac Monitor (eCordum CM)?
The FDA 510(k) record lists Ecordum, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for eCordum Cardiac Monitor (eCordum CM)?
The FDA product code for eCordum Cardiac Monitor (eCordum CM) is DXH. This falls under the Hematology category.
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相關器械（代碼：DXH）
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。
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