TUTTNAUER TABLE-TOP AUTOCLAVE— 510(k) K973550

Substantially Equivalent

Tuttnauer U.S.A Co, Ltd.

FDA 510(k) clearance K973550 for TUTTNAUER TABLE-TOP AUTOCLAVE, Substantially Equivalent on 1997-10-29. 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: 1997-09-18
Decision date: 1997-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington D.C., DC, US

Download summary PDF View on FDA.gov ↗

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.