510(k) K844149— AMBU RUBEN CIRCLE ANESTHESIA SYSTEM

Substantially Equivalent

Ambu, Inc.

Clearance details

Applicant: Ambu, Inc.
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1984-10-24
Decision date: 1984-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, US

Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.