Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable— 510(k) K203749

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K203749 for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable, Substantially Equivalent on 2021-05-03. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code CBI
Advisory panel: Anesthesiology
Date received: 2020-12-23
Decision date: 2021-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

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.