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FDA 510(k)

Pressio 3 Multi-parameter Neuromonitoring System

K-Number: K252241 · 2026-04-10

ApplicantSophysa
Decision Date2026-04-10
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Pressio 3 Multi-parameter Neuromonitoring System is a medical device manufactured by Sophysa. It received FDA 510(k) clearance on 2026-04-10 under approval number K252241. 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 3 Multi-parameter Neuromonitoring System?

Pressio 3 Multi-parameter Neuromonitoring System is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Sophysa. The 510(k) number is K252241.

When was Pressio 3 Multi-parameter Neuromonitoring System approved by the FDA?

Pressio 3 Multi-parameter Neuromonitoring System received FDA 510(k) clearance on 2026-04-10, under approval number K252241.

What company makes Pressio 3 Multi-parameter Neuromonitoring System?

Pressio 3 Multi-parameter Neuromonitoring System is manufactured by Sophysa.

What is the FDA product code for Pressio 3 Multi-parameter Neuromonitoring System?

The FDA product code for Pressio 3 Multi-parameter Neuromonitoring System is GWM.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

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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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