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ABL90 Flex Analyzer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131988

by Radiometer Medical ApS

Identifiers

510(k) Number
K131988 FDA 510(k)
FDA Product Code
CHL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1120 FDA 510(k)
Regulation Number
862.1120 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Abl90 Flex Analyzer is an Electrode Measurement device for Blood-Gases (Pco2, Po2) and Blood Ph. It is a clinical chemistry device used for analyzing blood gas parameters. The device provides 17 parameters in a short time from a small sample size.

The Abl90 Flex Analyzer is supplied with automated built-in quality control and is designed to work alongside hospital security measures to prevent cyberattacks. It has an FDA 510K authorization and is classified under the product code CHL. The device is used in clinical settings and its specifications include a range of registration numbers and a regulation number of 862.1120.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Blood gas analyzer - ABL90 FLEX - Radiometer, ABL90 FLEX PLUS blood gas analyzer - Radiometer America, Radiometer ABL90 FLEX Blood Gas Analyzer - Medical XPRT, RADIOMETER ABL90 FLEX REFERENCE MANUAL Pdf Download

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Radiometer Medical ApS

Sources (1)

  • FDA 510(k) K131988 24 fields · synced Sep 24, 2026