510(k) K162523
- Device
- The IQool System
- Applicant
- BRAIN COOL AB
- 510(k) number
- K162523
- Product code
- NZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-05-03
- Date received
- 2016-09-09
- Regulation
- 870.5900
- Classification name
- Hyperthermia Monitor
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN WALEIJ
- Address
- Scheelevagen 2 Medicon Village Medicon Village SE SE-223 81 SE-223 81
FDA Registration Numbers#
- 3029871637
- 3009420598
- 3006059109
- 3010617000
Source Documents#
Other 510(k) Records For Product Code NZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250979 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) | Zoll Circulation, Inc. | 2025-10-15 |
| K240933 | CarbonCool® System | Global Healthcare SG Sdn. Bhd | 2025-03-18 |
| K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System | Zoll Circulation, Inc. | 2023-11-03 |
| K100071 | EMCOOLSPAD | Emcools Emergency Medical Cooling Systems AG | 2010-10-12 |
| K061023 | THERMOSUIT SYSTEM | Life Recovery Systems Hd, LLC | 2006-09-20 |
Legacy Summary#
summary
FDA Review#
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