TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP— 510(k) K993856

Substantially Equivalent

Tuttnauer U.S.A Co, Ltd.

FDA 510(k) clearance K993856 for TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP, Substantially Equivalent on 2001-02-09. Applicant: Tuttnauer U.S.A Co, Ltd..

Clearance details

Applicant: Tuttnauer U.S.A Co, Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1999-11-15
Decision date: 2001-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
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.