MXM

Cap, Cooling (Infants)

Product code: MXM
Device name: Cap, Cooling (Infants)
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

Indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE)*. Provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: MXM

Classification and pathway per current FDA publications. Data from openFDA (CC0).