510(k) K100071

EMCOOLSPAD by Emcools Emergency Medical Cooling Systems AG — Product Code NZE

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).

510(k) K100071

Clearance Details

Device Classification

Other clearances for product code NZE