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510(k) K252207

ABL90 FLEX PLUS System, safeCLINITUBES by Radiometer Medicals Aps — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2026
Date Received
July 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type

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