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FDA 510(k)

ABL500 BLOOD GAS SYSTEM

K-Number: K895181 · 1989-10-06

ApplicantRadiometer America, Inc.
Decision Date1989-10-06
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL500 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 1989-10-06 under 510(k) number K895181. 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 ABL500 BLOOD GAS SYSTEM?

ABL500 BLOOD GAS SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Radiometer America, Inc.. The 510(k) number is K895181.

When did ABL500 BLOOD GAS SYSTEM receive FDA 510(k) clearance?

ABL500 BLOOD GAS SYSTEM received FDA 510(k) clearance on 1989-10-06, under 510(k) number K895181.

Who is the listed applicant for ABL500 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 ABL500 BLOOD GAS SYSTEM?

The FDA product code for ABL500 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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