MXM — Cap, Cooling (Infants) Class III
FDA product code MXM covers "Cap, Cooling (Infants)", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- MXM
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Unknown
- Implant
- No
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.