FDA 510(k)

IASIS i2 Relaxation Neurofeedback System

Número K: K252923 · 2026-03-13

Data da decisão2026-03-13

Código do produto

DecisãoSubstantially Equivalent

Resumo do dispositivo

IASIS i2 Relaxation Neurofeedback System is the device name listed in this FDA 510(k) record. The listed applicant is Iasis Technologies. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K252923. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IASIS i2 Relaxation Neurofeedback System?

IASIS i2 Relaxation Neurofeedback System is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Iasis Technologies. The 510(k) number is K252923.

When did IASIS i2 Relaxation Neurofeedback System receive FDA 510(k) clearance?

IASIS i2 Relaxation Neurofeedback System received FDA 510(k) clearance on 2026-03-13, under 510(k) number K252923.

Who is the listed applicant for IASIS i2 Relaxation Neurofeedback System?

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

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