FDA 510(k)

Neuralytix iD3 系统 (NTX-9001)

K号: K243636 · 2025-06-26

决定日期2025-06-26

产品代码PDQ

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决定实质等同

器械摘要

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.

常见问题

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.

官方来源

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Neuralytix iD3 系统 (NTX-9001)

器械摘要

常见问题

相关临床试验

相关器械（代码：PDQ）

官方来源