Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2— 510(k) K220606

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K220606 for Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2, Substantially Equivalent on 2022-07-25. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2022-03-02
Decision date: 2022-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

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.