AMBU WHITE SENSOR CFM, CFL— 510(k) K052944

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K052944 for AMBU WHITE SENSOR CFM, CFL, Substantially Equivalent on 2006-10-25. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 2005-10-20
Decision date: 2006-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glen Burnie, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.