Ambu aScope RLS Slim— 510(k) K181286

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K181286 for Ambu aScope RLS Slim, Substantially Equivalent on 2018-11-30. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2018-05-16
Decision date: 2018-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
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.