510(k) K223782— Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set

Substantially Equivalent

Ambu A/S

Clearance details

Applicant: Ambu A/S
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2022-12-16
Decision date: 2023-01-12
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.