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FDA 510(k)

ABL 735 ANALYZER

K-Number: K991417 · 1999-11-24

ApplicantRadiometer America, Inc.
Decision Date1999-11-24
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL 735 ANALYZER 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 1999-11-24 under 510(k) number K991417. 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 ABL 735 ANALYZER?

ABL 735 ANALYZER is a medical device that received FDA 510(k) clearance on 1999-11-24. The listed applicant is Radiometer America, Inc.. The 510(k) number is K991417.

When did ABL 735 ANALYZER receive FDA 510(k) clearance?

ABL 735 ANALYZER received FDA 510(k) clearance on 1999-11-24, under 510(k) number K991417.

Who is the listed applicant for ABL 735 ANALYZER?

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 ABL 735 ANALYZER?

The FDA product code for ABL 735 ANALYZER is CHL.

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Other records listing Radiometer America, Inc. as applicant

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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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