FDA 510(k)

ABL90 FLEX, ABL90 FLEX PLUS

K 號：K170882 · 2017-04-28

決定日期2017-04-28

產品代碼MQM

諮詢委員會CH

決定相當於

器材摘要

ABL90 FLEX, 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 2017-04-28 under 510(k) number K170882. The device is classified under product code MQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ABL90 FLEX, ABL90 FLEX PLUS?

ABL90 FLEX, ABL90 FLEX PLUS is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Radiometer Medical Aps. The 510(k) number is K170882.

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

ABL90 FLEX, ABL90 FLEX PLUS received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170882.

Who is the listed applicant for ABL90 FLEX, 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, ABL90 FLEX PLUS?

The FDA product code for ABL90 FLEX, ABL90 FLEX PLUS is MQM.

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。

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官方來源

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