510(k) K161656— Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor

Substantially Equivalent

Ambu A/S

Clearance details

Applicant: Ambu A/S
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2016-06-16
Decision date: 2016-09-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Ballerup, DK

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.