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FDA 510(k)

iPhysio® System

K-Number: K232383 · 2025-03-04

ApplicantEuroteknika
Decision Date2025-03-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

iPhysio® System is a medical device manufactured by Euroteknika. It received FDA 510(k) clearance on 2025-03-04 under approval number K232383. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iPhysio® System?

iPhysio® System is a medical device that received FDA 510(k) clearance on 2025-03-04. It is manufactured by Euroteknika. The 510(k) number is K232383.

When was iPhysio® System approved by the FDA?

iPhysio® System received FDA 510(k) clearance on 2025-03-04, under approval number K232383.

What company makes iPhysio® System?

iPhysio® System is manufactured by Euroteknika.

What is the FDA product code for iPhysio® System?

The FDA product code for iPhysio® System is NHA.

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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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