510(k) K820709— AIRWAYS

Substantially Equivalent

Seven Harvest Intl. Import & Export

Clearance details

Applicant: Seven Harvest Intl. Import & Export
Product code: Code CAE
Advisory panel: Anesthesiology
Date received: 1982-03-18
Decision date: 1982-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code CAE

product code CAE

Death: 4
Total: 4

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.