FDA 510(k)

ABL90 FLEX PLUS

K 號：K160153 · 2016-11-04

決定日期2016-11-04

產品代碼CHL

諮詢委員會CH

決定相當於

器材摘要

ABL90 FLEX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K160153. 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 ABL90 FLEX PLUS?

ABL90 FLEX PLUS is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Radiometer Medical Aps. The 510(k) number is K160153.

When did ABL90 FLEX PLUS receive FDA 510(k) clearance?

ABL90 FLEX PLUS received FDA 510(k) clearance on 2016-11-04, under 510(k) number K160153.

Who is the listed applicant for ABL90 FLEX PLUS?

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

What is the FDA product code for ABL90 FLEX PLUS?

The FDA product code for ABL90 FLEX PLUS is CHL.

其他以 Radiometer Medical Aps 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。

K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX K170882ABL90 FLEX, ABL90 FLEX PLUS

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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