ABL500 BLOOD GAS SYSTEM— 510(k) K895181

Substantially Equivalent

Radiometer America, Inc.

FDA 510(k) clearance K895181 for ABL500 BLOOD GAS SYSTEM, Substantially Equivalent on 1989-10-06. Applicant: Radiometer America, Inc..

Clearance details

Applicant: Radiometer America, Inc.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 1989-08-11
Decision date: 1989-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake, OH, US

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Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.