NZE · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5900
Classification
FDA Product Code
NZE
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.5900
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
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).