SENTRY— 510(k) K792653

Substantially Equivalent

Automated Screening Devices

FDA 510(k) clearance K792653 for SENTRY, Substantially Equivalent on 1980-01-04. Applicant: Automated Screening Devices.

Clearance details

Applicant: Automated Screening Devices
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1979-12-26
Decision date: 1980-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.