MXM · Cap, Cooling (Infants)
· Class 3
Overview
| Product Code | MXM |
|---|---|
| Device Name | Cap, Cooling (Infants) |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P040025 | OLYMPIC COOL-CAP | Natus Medical Incorporated | Dec 20, 2006 | APWD |
Top Applicants
- Natus Medical Incorporated — 1 clearance
