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FDA 510(k)

ABL8X7 FLEX

K-Number: K051968 · 2006-10-16

ApplicantRadiometer Medical Aps
Decision Date2006-10-16
Product CodeCGL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL8X7 FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2006-10-16 under 510(k) number K051968. The device is classified under product code CGL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABL8X7 FLEX?

ABL8X7 FLEX is a medical device that received FDA 510(k) clearance on 2006-10-16. The listed applicant is Radiometer Medical Aps. The 510(k) number is K051968.

When did ABL8X7 FLEX receive FDA 510(k) clearance?

ABL8X7 FLEX received FDA 510(k) clearance on 2006-10-16, under 510(k) number K051968.

Who is the listed applicant for ABL8X7 FLEX?

The FDA 510(k) record lists Radiometer Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABL8X7 FLEX?

The FDA product code for ABL8X7 FLEX is CGL.

Other records listing Radiometer Medical Aps as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXK170882ABL90 FLEX, ABL90 FLEX PLUSK160153ABL90 FLEX PLUSK131988ABL90 FLEX ANALYZERK130144ABL90 FLEXK123748ABL90 FLEX

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Related Devices (Code: CGL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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