DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET— 510(k) K132202

Substantially Equivalent

Enthermics Medical Systems, Inc.

FDA 510(k) clearance K132202 for DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET, Substantially Equivalent on 2013-12-06. Applicant: Enthermics Medical Systems, Inc..

Clearance details

Applicant: Enthermics Medical Systems, Inc.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2013-07-16
Decision date: 2013-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menomonee Falls, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.