Panels › Cardiovascular › Product code NZE · Class 2
Hyperthermia Monitor
Regulation 870.5900
0510(k)s in 12 months (6 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Life Recovery Systems Hd, LLC | 1 | 1 |
| Zoll Circulation, Inc. | 2 | 0 |
| Braincool AB | 1 | 0 |
| Emcools Emergency Medical Cooling Systems AG | 1 | 0 |
| Global Healthcare SG Sdn. Bhd | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2025 | K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) Zoll Circulation, Inc. | NZE |
| Mar 18, 2025 | K240933 | CarbonCool® System Global Healthcare SG Sdn. Bhd, MY | NZE |
| Nov 3, 2023 | K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System Zoll Circulation, Inc. | NZE |
| May 3, 2017 | K162523 | The IQool System Braincool AB, SE | NZE |
| Oct 12, 2010 | K100071 | EMCOOLSPAD Emcools Emergency Medical Cooling Systems AG, AT | NZE |
| Sep 20, 2006 | K061023 | THERMOSUIT SYSTEM Life Recovery Systems Hd, LLC | NZE |
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