The IQool System
FDA 510(k) K162523 · Braincool AB
510(k) numberK162523
Submission
- Device name
- The IQool System
- Applicant
- Braincool AB
Medicon Village, SE - Received
- September 9, 2016
- Decision date
- May 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NZE – Hyperthermia Monitor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius. To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions).
Other 510(k)s with product code NZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management…NZE · Traditional | Zoll Circulation, Inc. | 10/15/2025SE |
| K240933 | CarbonCool® SystemNZE · Traditional | Global Healthcare SG Sdn. Bhd | 03/18/2025SE |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management SystemNZE · Traditional | Zoll Circulation, Inc. | 11/03/2023SE |
| K100071 | EmcoolspadNZE · Traditional | Emcools Emergency Medical Cooling Systems AG | 10/12/2010SE |
| K061023 | Thermosuit SystemNZE · Traditional | Life Recovery Systems Hd, LLC | 09/20/2006SE |
More from Life Recovery Systems Hd, LLC
Questions and answers
When was The IQool System cleared by the FDA?
The IQool System (K162523) received a 510(k) decision of Substantially Equivalent on May 3, 2017, 236 days after the submission was received.
What is the product code of K162523?
The FDA product code is NZE – Hyperthermia Monitor, a Class II (moderate risk) device regulated under 21 CFR 870.5900.