510(k) K100129— AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

Substantially Equivalent

Ambu A/S

Clearance details

Applicant: Ambu A/S
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 2010-01-19
Decision date: 2010-06-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Glen Burnie, MD, US

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.