NZE · Hyperthermia Monitor
Cardiovascular · 21 CFR 870.5900 · Class 2
Overview
| Product Code | NZE |
|---|---|
| Device Name | Hyperthermia Monitor |
| Regulation | 21 CFR 870.5900 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | Zoll Circulation, Inc. | Oct 15, 2025 | SESE |
| K240933 | CarbonCool® System | Global Healthcare SG Sdn. Bhd | Mar 18, 2025 | SESE |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | Zoll Circulation, Inc. | Nov 3, 2023 | SESE |
| K162523 | The IQool System | Braincool AB | May 3, 2017 | SESE |
| K100071 | EMCOOLSPAD | Emcools Emergency Medical Cooling Systems AG | Oct 12, 2010 | SESE |
| K061023 | THERMOSUIT SYSTEM | Life Recovery Systems Hd, LLC | Sep 20, 2006 | SESE |
Top Applicants
- Zoll Circulation, Inc. — 2 clearances
- Braincool AB — 1 clearance
- Emcools Emergency Medical Cooling Systems AG — 1 clearance
- Global Healthcare SG Sdn. Bhd — 1 clearance
- Life Recovery Systems Hd, LLC — 1 clearance
