K231182 is an FDA 510(k) clearance for the Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System. This device is classified as a Hyperthermia Monitor (Class II - Special Controls, product code NZE).
Submitted by Zoll Circulation, Inc. (San Jose, US). The FDA issued a Cleared decision on November 3, 2023, 191 days after receiving the submission on April 26, 2023.
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 | K231182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2023 |
| Decision Date | November 03, 2023 |
| Days to Decision | 191 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). |