K162523 is an FDA 510(k) clearance for the The IQool System. This device is classified as a Hyperthermia Monitor (Class II - Special Controls, product code NZE).
Submitted by Braincool AB (Medicon Village, SE). The FDA issued a Cleared decision on May 3, 2017, 236 days after receiving the submission on September 9, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5900. Intended To Monitor And Reduce A Patient's Temperature To Mild Hypothermia (not To Go Below 32 Degrees Celsius. To Induce Mild Hypothermia In Hyperthermic Patients E.g., Heat Stroke, Fever (excluding Fever Related To Head Injury, Cardiac Arrest, Or Other Severe Medical Conditions)..
| 510(k) Number | K162523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2016 |
| Decision Date | May 03, 2017 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NZE — Hyperthermia Monitor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5900 |
| Definition | Intended To Monitor And Reduce A Patient's Temperature To Mild Hypothermia (not To Go Below 32 Degrees Celsius. To Induce Mild Hypothermia In Hyperthermic Patients E.g., Heat Stroke, Fever (excluding Fever Related To Head Injury, Cardiac Arrest, Or Other Severe Medical Conditions). |