DUO-TEL— 510(k) K810331

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K810331 for DUO-TEL, Substantially Equivalent on 1981-03-20. Applicant: General Electric Co..

Clearance details

Applicant: General Electric Co.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 1981-02-09
Decision date: 1981-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.