FDA Product Code NZE: Hyperthermia Monitor
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).
Leading manufacturers include Zoll Circulation, Inc. and Global Healthcare SG Sdn. Bhd.
FDA 510(k) Cleared Hyperthermia Monitor Devices (Product Code NZE)
About Product Code NZE - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code NZE since 2006, with 6 receiving FDA clearance (average review time: 234 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NZE have taken an average of 273 days to reach a decision - up from 215 days historically. Manufacturers should account for longer review timelines in current project planning.
NZE devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →