EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870— 510(k) K003470

Substantially Equivalent

Tuttnauer Co. , Ltd.

FDA 510(k) clearance K003470 for EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870, Substantially Equivalent on 2001-02-20. Applicant: Tuttnauer Co. , Ltd..

Clearance details

Applicant: Tuttnauer Co. , Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2000-11-08
Decision date: 2001-02-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Washington, DC, 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.