PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V— 510(k) K032192

Name: FDA 510(k) clearance K032192
Creator: U.S. Food and Drug Administration
Published: 2004-08-12

Substantially Equivalent

Tuttnauer U.S.A Co, Ltd.

FDA 510(k) clearance K032192 for PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V, Substantially Equivalent on 2004-08-12. Applicant: Tuttnauer U.S.A Co, Ltd.. Device class: 2.

Clearance details

Applicant: Tuttnauer U.S.A Co, Ltd.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2003-07-17
Decision date: 2004-08-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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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.