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FDA 510(k)

ABL505 BLOOD GAS & ELECTROLYTE SYSTEM

K-Number: K914166 · 1992-01-28

ApplicantRadiometer America, Inc.
Decision Date1992-01-28
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL505 BLOOD GAS & ELECTROLYTE 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 1992-01-28 under 510(k) number K914166. 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 ABL505 BLOOD GAS & ELECTROLYTE SYSTEM?

ABL505 BLOOD GAS & ELECTROLYTE SYSTEM is a medical device that received FDA 510(k) clearance on 1992-01-28. The listed applicant is Radiometer America, Inc.. The 510(k) number is K914166.

When did ABL505 BLOOD GAS & ELECTROLYTE SYSTEM receive FDA 510(k) clearance?

ABL505 BLOOD GAS & ELECTROLYTE SYSTEM received FDA 510(k) clearance on 1992-01-28, under 510(k) number K914166.

Who is the listed applicant for ABL505 BLOOD GAS & ELECTROLYTE 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 ABL505 BLOOD GAS & ELECTROLYTE SYSTEM?

The FDA product code for ABL505 BLOOD GAS & ELECTROLYTE SYSTEM is CHL.

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Other records listing Radiometer America, Inc. as applicant

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Related Devices (Code: 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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