510(k) K061023

THERMOSUIT SYSTEM by Life Recovery Systems Hd, LLC — Product Code NZE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 20, 2006
Date Received: April 13, 2006
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).

510(k) K061023

Clearance Details

Device Classification

Other clearances for product code NZE