K894337

Substantially Equivalent

UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM

Applicant: Vitaid, Ltd.
Product code: CBI
Advisory panel: Anesthesiology
Date received: 1989-07-14
Decision date: 1989-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, Canada, CA

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.