ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX— 510(k) K043218

Substantially Equivalent

Radiometer Medical Aps

FDA 510(k) clearance K043218 for ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX, Substantially Equivalent on 2005-05-10. Applicant: Radiometer Medical Aps.

Clearance details

Applicant: Radiometer Medical Aps
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2004-11-22
Decision date: 2005-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bronshoj, DK

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.