ATGM MODEL AT-80— 510(k) K802191

Substantially Equivalent

Herald of America, Inc.

FDA 510(k) clearance K802191 for ATGM MODEL AT-80, Substantially Equivalent on 1980-11-12. Applicant: Herald of America, Inc..

Clearance details

Applicant: Herald of America, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1980-09-10
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.