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FDA 510(k)

ABL510 BLOOD GAS SYSTEM

K-Number: K904513 · 1990-12-13

ApplicantRadiometer America, Inc.
Decision Date1990-12-13
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL510 BLOOD GAS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1990-12-13 under 510(k) number K904513. 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 ABL510 BLOOD GAS SYSTEM?

ABL510 BLOOD GAS SYSTEM is a medical device that received FDA 510(k) clearance on 1990-12-13. The listed applicant is Radiometer America, Inc.. The 510(k) number is K904513.

When did ABL510 BLOOD GAS SYSTEM receive FDA 510(k) clearance?

ABL510 BLOOD GAS SYSTEM received FDA 510(k) clearance on 1990-12-13, under 510(k) number K904513.

Who is the listed applicant for ABL510 BLOOD GAS SYSTEM?

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

What is the FDA product code for ABL510 BLOOD GAS SYSTEM?

The FDA product code for ABL510 BLOOD GAS SYSTEM is CHL.

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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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