GETINGE 800HC- SERIES STEAM STERILIZER— 510(k) K122625

Substantially Equivalent

Getinge Sourcing, LLC

FDA 510(k) clearance K122625 for GETINGE 800HC- SERIES STEAM STERILIZER, Substantially Equivalent on 2013-05-22. Applicant: Getinge Sourcing, LLC.

Clearance details

Applicant: Getinge Sourcing, LLC
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2012-08-28
Decision date: 2013-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, 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.