FDA 510(k)

EasyStat 300

K 號：K211559 · 2023-01-27

決定日期2023-01-27

產品代碼CHL

諮詢委員會CH

決定相當於

器材摘要

EasyStat 300 is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corporation. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K211559. 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 EasyStat 300?

EasyStat 300 is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Medica Corporation. The 510(k) number is K211559.

When did EasyStat 300 receive FDA 510(k) clearance?

EasyStat 300 received FDA 510(k) clearance on 2023-01-27, under 510(k) number K211559.

Who is the listed applicant for EasyStat 300?

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

What is the FDA product code for EasyStat 300?

The FDA product code for EasyStat 300 is CHL.

其他以 Medica Corporation 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。

K220328EasyStat 300 K220396EasyStat 300 K152327EasyLyte 钠/鈣/氯/鈣分析儀

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。

K252207ABL90 FLEX PLUS 系統，safeCLINITUBESRadiometer Medicals Aps K244014i-STAT CG4+ 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.K240998ABL90 FLEX PLUS 系統Radiometer Medicals Aps K230285i-STAT CG8+ 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.K221900統計配置文件Prime Plus分析系統Nova Biomedical Corporation K223857i-STAT G3+ 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.

官方來源

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