ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM— 510(k) K943882

Substantially Equivalent

Radiometer America, Inc.

FDA 510(k) clearance K943882 for ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM, Substantially Equivalent on 1995-03-10. Applicant: Radiometer America, Inc..

Clearance details

Applicant: Radiometer America, Inc.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 1994-08-09
Decision date: 1995-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake, OH, US

Download summary PDF View on FDA.gov ↗

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.