FDA 510(k)

Neuralytix iD3 System (NTX-9001)

Número K: K243636 · 2025-06-26

Data da decisão2025-06-26

Código do produtoPDQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Neuralytix iD3 System (NTX-9001) is the device name listed in this FDA 510(k) record. The listed applicant is Neuralytix, LLC. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K243636. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Neuralytix iD3 System (NTX-9001)?

Neuralytix iD3 System (NTX-9001) is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Neuralytix, LLC. The 510(k) number is K243636.

When did Neuralytix iD3 System (NTX-9001) receive FDA 510(k) clearance?

Neuralytix iD3 System (NTX-9001) received FDA 510(k) clearance on 2025-06-26, under 510(k) number K243636.

Who is the listed applicant for Neuralytix iD3 System (NTX-9001)?

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

What is the FDA product code for Neuralytix iD3 System (NTX-9001)?

The FDA product code for Neuralytix iD3 System (NTX-9001) is PDQ.

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