510(k) K053645— MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS

Substantially Equivalent

Arizant Healthcare, Inc.

Clearance details

Applicant: Arizant Healthcare, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2005-12-30
Decision date: 2006-03-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, 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.