The IQoolTM Warm System— 510(k) K180375

Substantially Equivalent

Braincool AB

FDA 510(k) clearance K180375 for The IQoolTM Warm System, Substantially Equivalent on 2018-05-18. Applicant: Braincool AB.

Clearance details

Applicant: Braincool AB
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2018-02-12
Decision date: 2018-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medicon Village, SE

Download summary PDF View on FDA.gov ↗

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.