ABL90 FLEX— 510(k) K120197

Substantially Equivalent

Radiometer Medical Aps

FDA 510(k) clearance K120197 for ABL90 FLEX, Substantially Equivalent on 2012-03-19. Applicant: Radiometer Medical Aps.

Clearance details

Applicant: Radiometer Medical Aps
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2012-01-23
Decision date: 2012-03-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Broenshoej, 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.