510(k) K162523
K162523 is an FDA 510(k) premarket notification submitted by Braincool AB for the device "The IQool System". The FDA issued a decision of Substantially Equivalent on May 3, 2017. The device falls under product code NZE (Hyperthermia Monitor), a Class II device regulated under 21 CFR 870.5900. Braincool AB has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2017
- Date Received
- September 9, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hyperthermia Monitor
- Device Class
- Class II
- Regulation Number
- 870.5900
- Review Panel
- CV
- Submission Type
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).