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FDA 510(k)

ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX

K-Number: K043218 · 2005-05-10

ApplicantRadiometer Medical Aps
Decision Date2005-05-10
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX 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 2005-05-10 under 510(k) number K043218. 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 ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX?

ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX is a medical device that received FDA 510(k) clearance on 2005-05-10. The listed applicant is Radiometer Medical Aps. The 510(k) number is K043218.

When did ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX receive FDA 510(k) clearance?

ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX received FDA 510(k) clearance on 2005-05-10, under 510(k) number K043218.

Who is the listed applicant for ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX?

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 ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX?

The FDA product code for ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX is CHL.

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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.

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Related Devices (Code: CHL)

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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