IRMA C02 MODEL 200101; IRMA AX 200601— 510(k) K123043

Substantially Equivalent

Phasein AB

FDA 510(k) clearance K123043 for IRMA C02 MODEL 200101; IRMA AX 200601, Substantially Equivalent on 2012-10-25. Applicant: Phasein AB.

Clearance details

Applicant: Phasein AB
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2012-09-28
Decision date: 2012-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.