510(k) K040440— HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)

Substantially Equivalent

Http Hypothermia Therapy

Clearance details

Applicant: Http Hypothermia Therapy
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2004-02-20
Decision date: 2004-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

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.