510(k) K953938— STERILEMAX

Substantially Equivalent

Barnstead/Thermolyne Corp.

Clearance details

Applicant: Barnstead/Thermolyne Corp.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1995-08-21
Decision date: 1997-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dubuque, IA, US

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.