510(k) K100071
K100071 is an FDA 510(k) premarket notification submitted by Emcools Emergency Medical Cooling Systems AG for the device "EMCOOLSPAD". The FDA issued a decision of Substantially Equivalent on October 12, 2010. 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
- October 12, 2010
- Date Received
- January 11, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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).