GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER— 510(k) K070657

Substantially Equivalent

Getinge Sourcing, LLC

FDA 510(k) clearance K070657 for GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER, Substantially Equivalent on 2007-04-05. Applicant: Getinge Sourcing, LLC.

Clearance details

Applicant: Getinge Sourcing, LLC
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2007-03-09
Decision date: 2007-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, 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.