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FDA 510(k)

ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM

K-Number: K943882 · 1995-03-10

ApplicantRadiometer America, Inc.
Decision Date1995-03-10
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH 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 1995-03-10 under 510(k) number K943882. 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 ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM?

ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is Radiometer America, Inc.. The 510(k) number is K943882.

When did ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM receive FDA 510(k) clearance?

ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM received FDA 510(k) clearance on 1995-03-10, under 510(k) number K943882.

Who is the listed applicant for ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH 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 ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM?

The FDA product code for ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM is CHL.

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Other records listing Radiometer America, Inc. as applicant

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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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