FDA 510(k)

ABL90 FLEX PLUS

K-Number: K160153 · 2016-11-04

Decision Date2016-11-04

Product CodeCHL

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ABL90 FLEX PLUS is a medical device manufactured by Radiometer Medical Aps. It received FDA 510(k) clearance on 2016-11-04 under approval number K160153. 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?

ABL90 FLEX PLUS is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Radiometer Medical Aps. The 510(k) number is K160153.

When was ABL90 FLEX PLUS approved by the FDA?

ABL90 FLEX PLUS received FDA 510(k) clearance on 2016-11-04, under approval number K160153.

What company makes ABL90 FLEX PLUS?

ABL90 FLEX PLUS is manufactured by Radiometer Medical Aps.

What is the FDA product code for ABL90 FLEX PLUS?

The FDA product code for ABL90 FLEX PLUS is CHL.

Other Devices by Radiometer Medical Aps

K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX K170882ABL90 FLEX, ABL90 FLEX PLUS

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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.