# MXM · Cap, Cooling (Infants)

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/NE-misc/MXM

## Overview

- **Product Code:** MXM
- **Device Name:** Cap, Cooling (Infants)
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## 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](https://fda.innolitics.com/submissions/NE/NE-misc/MXM/P040025.md) | OLYMPIC COOL-CAP | Natus Medical Incorporated | Dec 20, 2006 | APWD |

## Top Applicants

- Natus Medical Incorporated — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/NE/NE-misc/MXM](https://fda.innolitics.com/submissions/NE/NE-misc/MXM)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com