FDA Product Code
FDA Product Code NZE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5900
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | Zoll Circulation, Inc. | 2025-10-15 | Traditional | PDF ↗ |
| K240933 | CarbonCool® System | Global Healthcare SG Sdn. Bhd | 2025-03-18 | Traditional | PDF ↗ |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | Zoll Circulation, Inc. | 2023-11-03 | Traditional | PDF ↗ |
| K162523 | The IQool System | Braincool AB | 2017-05-03 | Traditional | PDF ↗ |
| K100071 | EMCOOLSPAD | Emcools Emergency Medical Cooling Systems AG | 2010-10-12 | Traditional | PDF ↗ |
| K061023 | THERMOSUIT SYSTEM | Life Recovery Systems Hd, LLC | 2006-09-20 | Traditional | PDF ↗ |
Product code NZE · Class II · Cardiovascular. Data: openFDA.