STERILIZER, EAGLE 2000— 510(k) K781684

Substantially Equivalent

American Sterilizer Co.

FDA 510(k) clearance K781684 for STERILIZER, EAGLE 2000, Substantially Equivalent on 1978-10-24. Applicant: American Sterilizer Co..

Clearance details

Applicant: American Sterilizer Co.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1978-10-02
Decision date: 1978-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.