FDA 510(k)

Pressio 3 Multi-parameter Neuromonitoring System

Número K: K252241 · 2026-04-10

Data da decisão2026-04-10

Código do produtoGWM

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pressio 3 Multi-parameter Neuromonitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Sophysa. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252241. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Sophysa. The 510(k) number is K252241.

When did Pressio 3 Multi-parameter Neuromonitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for Pressio 3 Multi-parameter Neuromonitoring System?

The FDA 510(k) record lists Sophysa as the applicant. This does not by itself establish the device manufacturer.

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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