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Pressio 2 ICP Monitoring System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162108

by Sophysa SA

Identifiers

510(k) Number
K162108 FDA 510(k)
FDA Product Code
GWM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1620 FDA 510(k)
Regulation Number
882.1620 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pressio 2 ICP Monitoring System is a device for monitoring intracranial pressure and intracranial temperature in real time. It consists of the Pressio 2 ICP Monitor and dedicated Pressio Catheters, providing a complete solution for simultaneous measurement of intracranial pressure and temperature.

The system is supplied as a tabletop patient monitor and is intended for use in clinical settings. It is authorized under FDA 510(k) clearance K162108 and is classified as a Class II device under regulation number 882.1620 with product code GWM.

Frequently asked questions

What is the Pressio 2 ICP Monitoring System used for?

The Pressio 2 ICP Monitoring System is used for real-time monitoring of intracranial pressure and intracranial temperature. It consists of the Pressio 2 ICP Monitor and dedicated Pressio Catheters, providing a complete solution for simultaneous measurement of both parameters in clinical settings.

How is the Pressio 2 ICP Monitoring System supplied and configured for use?

The system is supplied as a tabletop patient monitor and includes the Pressio 2 ICP Monitor and dedicated Pressio Catheters. It is designed for use in clinical settings to enable simultaneous real-time monitoring of intracranial pressure and temperature.

What regulatory pathway was used for the Pressio 2 ICP Monitoring System, and what is its classification?

The Pressio 2 ICP Monitoring System was authorized under FDA 510(k) clearance K162108 and is classified as a Class II medical device under regulation number 882.1620 with product code GWM.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pressio® 2 - Sophysa, PDF Pressio 2 - Sophysa USA, PDF Pressio 2 - sophysa.com, Tabletop patient monitor - Pressio® 2 - Sophysa - temperature / ICP ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sophysa SA

Sources (1)

  • FDA 510(k) K162108 24 fields · synced Sep 19, 2026