Ambu aScope 4 RhinoLaryngo Slim— 510(k) K191080

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K191080 for Ambu aScope 4 RhinoLaryngo Slim, Substantially Equivalent on 2019-05-22. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2019-04-24
Decision date: 2019-05-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.