K240933 is an FDA 510(k) clearance for the CarbonCool? System. This device is classified as a Hyperthermia Monitor (Class II - Special Controls, product code NZE).
Submitted by Global Healthcare SG Sdn. Bhd (Negeri Sembilan, MY). The FDA issued a Cleared decision on March 18, 2025, 347 days after receiving the submission on April 5, 2024.
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 | K240933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2024 |
| Decision Date | March 18, 2025 |
| Days to Decision | 347 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). |