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FDA 510(k) Applications for Medical Device Product Code "NZE"
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| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K162523 | BRAIN COOL AB | The IQool System | 05/03/2017 |
| K100071 | EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG | EMCOOLSPAD | 10/12/2010 |
| K240933 | Global Healthcare SG Sdn. Bhd | CarbonCool« System | 03/18/2025 |
| K061023 | LIFE RECOVERY SYSTEMS HD, LLC | THERMOSUIT SYSTEM | 09/20/2006 |
| K231182 | ZOLL Circulation, Inc | Thermogard HQÖ Temperature Management System, Thermogard XP« Temperature Management System | 11/03/2023 |