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FDA 510(k)

ABL90 FLEX, ABL90 FLEX PLUS

K-Number: K170882 · 2017-04-28

ApplicantRadiometer Medical Aps
Decision Date2017-04-28
Product CodeMQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL90 FLEX, ABL90 FLEX PLUS is a medical device manufactured by Radiometer Medical Aps. It received FDA 510(k) clearance on 2017-04-28 under approval number K170882. The device is classified under product code MQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABL90 FLEX, ABL90 FLEX PLUS?

ABL90 FLEX, ABL90 FLEX PLUS is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by Radiometer Medical Aps. The 510(k) number is K170882.

When was ABL90 FLEX, ABL90 FLEX PLUS approved by the FDA?

ABL90 FLEX, ABL90 FLEX PLUS received FDA 510(k) clearance on 2017-04-28, under approval number K170882.

What company makes ABL90 FLEX, ABL90 FLEX PLUS?

ABL90 FLEX, ABL90 FLEX PLUS is manufactured by Radiometer Medical Aps.

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

The FDA product code for ABL90 FLEX, ABL90 FLEX PLUS is MQM.

Other Devices by Radiometer Medical Aps

K160153ABL90 FLEX PLUS K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

Official Source

View on FDA Database →

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

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