The IQoolTM System— 510(k) K232844

Name: FDA 510(k) clearance K232844
Creator: U.S. Food and Drug Administration
Published: 2023-10-04

Substantially Equivalent

Braincool AB

FDA 510(k) clearance K232844 for The IQoolTM System, Substantially Equivalent on 2023-10-04. Applicant: Braincool AB. Device class: 2.

Clearance details

Applicant: Braincool AB
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2023-09-14
Decision date: 2023-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Lund, SE

Download summary PDF View on FDA.gov ↗

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More clearances from Braincool AB

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DEN210027 — The Cooral System2022-10-14
K180375 — The IQoolTM Warm System2018-05-18
K162523 — The IQool System2017-05-03

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.