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FDA 510(k)

ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM

K-Number: K973367 · 1997-10-06

ApplicantRadiometer America, Inc.
Decision Date1997-10-06
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE 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 1997-10-06 under 510(k) number K973367. 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 ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM?

ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-06. The listed applicant is Radiometer America, Inc.. The 510(k) number is K973367.

When did ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM receive FDA 510(k) clearance?

ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM received FDA 510(k) clearance on 1997-10-06, under 510(k) number K973367.

Who is the listed applicant for ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE 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 ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM?

The FDA product code for ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE 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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