510(k) K240933
K240933 is an FDA 510(k) premarket notification submitted by Global Healthcare SG Sdn. Bhd for the device "CarbonCool® System". The FDA issued a decision of Substantially Equivalent on March 18, 2025. The device falls under product code NZE (Hyperthermia Monitor), a Class II device regulated under 21 CFR 870.5900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2025
- Date Received
- April 5, 2024
- 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).