FDA 510(k)

epoc 體液分析系統

K 號：K200107 · 2020-06-05

決定日期2020-06-05

產品代碼CHL

諮詢委員會CH

決定相當於

器材摘要

epoc Blood Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Epocal, Inc.. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K200107. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the epoc Blood Analysis System?

epoc Blood Analysis System is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Epocal, Inc.. The 510(k) number is K200107.

When did epoc Blood Analysis System receive FDA 510(k) clearance?

epoc Blood Analysis System received FDA 510(k) clearance on 2020-06-05, under 510(k) number K200107.

Who is the listed applicant for epoc Blood Analysis System?

The FDA 510(k) record lists Epocal, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for epoc Blood Analysis System?

The FDA product code for epoc Blood Analysis System is CHL.

其他以 Epocal, Inc. 為申請人之記錄

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K171247epoc 血尿素氮測試，epoc 總二氧化碳測試

相關器械（代碼：CHL）

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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官方來源

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