AMBU ASCOPE AND MONITOR— 510(k) K093186

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K093186 for AMBU ASCOPE AND MONITOR, Substantially Equivalent on 2010-04-16. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2009-10-09
Decision date: 2010-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glen Burnie, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.