FDA 510(k)

ABL90 FLEX PLUS 系統

K 號：K252488 · 2026-05-01

決定日期2026-05-01

產品代碼CGA

諮詢委員會CH

決定相當於

器材摘要

ABL90 FLEX PLUS System is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medicals Aps. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K252488. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ABL90 FLEX PLUS System?

ABL90 FLEX PLUS System is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Radiometer Medicals Aps. The 510(k) number is K252488.

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

ABL90 FLEX PLUS System received FDA 510(k) clearance on 2026-05-01, under 510(k) number K252488.

Who is the listed applicant for ABL90 FLEX PLUS System?

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

What is the FDA product code for ABL90 FLEX PLUS System?

The FDA product code for ABL90 FLEX PLUS System is CGA.

其他以 Radiometer Medicals 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。

K252475ABL90 FLEX PLUS 系統 K252207ABL90 FLEX PLUS 系統，safeCLINITUBES K241037ABL90 FLEX PLUS 系統 K240998ABL90 FLEX PLUS 系統

相關器械（代碼：CGA）

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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