Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2— 510(k) K230428

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K230428 for Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2, Substantially Equivalent on 2023-08-10. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2023-02-17
Decision date: 2023-08-10
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.