Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1620](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1620) → PSP — Intracranial Pressure & Temperature Monitoring Kit

# PSP · Intracranial Pressure & Temperature Monitoring Kit

_Neurology · 21 CFR 882.1620 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/PSP

## Overview

- **Product Code:** PSP
- **Device Name:** Intracranial Pressure & Temperature Monitoring Kit
- **Regulation:** [21 CFR 882.1620](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1620)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/PSP](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/PSP)

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