K200225

Substantially Equivalent

Arctic Sun Stat Temperature Management System

Applicant: Medivance, Inc.
Product code: DWJ
Advisory panel: Cardiovascular
Date received: 2020-01-30
Decision date: 2020-02-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Louisville, CO, US

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.