FDA.reportPublic FDA data

510(k) K240998

Device
ABL90 FLEX PLUS System
Applicant
Radiometer Medicals Aps
510(k) number
K240998
Product code
CHL
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-13
Date received
2024-04-11
Regulation
862.1120
Classification name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Andrea Swingle
Address
Åkandevej Brønshøj DK 2700 2700

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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