FDA 510(k)

ABL90 FLEX PLUS System

K-Number: K240998 · 2024-12-13

Decision Date2024-12-13

Product CodeCHL

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ABL90 FLEX PLUS System is a medical device manufactured by Radiometer Medicals Aps. It received FDA 510(k) clearance on 2024-12-13 under approval number K240998. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABL90 FLEX PLUS System?

ABL90 FLEX PLUS System is a medical device that received FDA 510(k) clearance on 2024-12-13. It is manufactured by Radiometer Medicals Aps. The 510(k) number is K240998.

When was ABL90 FLEX PLUS System approved by the FDA?

ABL90 FLEX PLUS System received FDA 510(k) clearance on 2024-12-13, under approval number K240998.

What company makes ABL90 FLEX PLUS System?

ABL90 FLEX PLUS System is manufactured by Radiometer Medicals Aps.

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

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

Other Devices by Radiometer Medicals Aps

K241037ABL90 FLEX PLUS System K252475ABL90 FLEX PLUS System K252488ABL90 FLEX PLUS System K252207ABL90 FLEX PLUS System, safeCLINITUBES

Related Devices (Code: CHL)

K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)Instrumentation Laboratory CO K160153ABL90 FLEX PLUSRadiometer Medical Aps K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit ControlEdan Instruments, Inc. K173403GEM Premier 5000Instrumentation Laboratory CO K173797Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation K200107epoc Blood Analysis SystemEpocal, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.