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FDA 510(k)

Pressio 2 ICP Monitoring System

K-Number: K162108 · 2017-04-17

ApplicantSophysa SA
Decision Date2017-04-17
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Pressio 2 ICP Monitoring System is a medical device manufactured by Sophysa SA. It received FDA 510(k) clearance on 2017-04-17 under approval number K162108. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pressio 2 ICP Monitoring System?

Pressio 2 ICP Monitoring System is a medical device that received FDA 510(k) clearance on 2017-04-17. It is manufactured by Sophysa SA. The 510(k) number is K162108.

When was Pressio 2 ICP Monitoring System approved by the FDA?

Pressio 2 ICP Monitoring System received FDA 510(k) clearance on 2017-04-17, under approval number K162108.

What company makes Pressio 2 ICP Monitoring System?

Pressio 2 ICP Monitoring System is manufactured by Sophysa SA.

What is the FDA product code for Pressio 2 ICP Monitoring System?

The FDA product code for Pressio 2 ICP Monitoring System is GWM.

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Related Devices (Code: GWM)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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