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FDA 510(k)

Layer 7-T

K-Number: K242618 · 2025-03-30

ApplicantPrecision Neuroscience, Corp.
Decision Date2025-03-30
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Layer 7-T is the device name listed in this FDA 510(k) record. The listed applicant is Precision Neuroscience, Corp.. It received FDA 510(k) clearance on 2025-03-30 under 510(k) number K242618. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Layer 7-T?

Layer 7-T is a medical device that received FDA 510(k) clearance on 2025-03-30. The listed applicant is Precision Neuroscience, Corp.. The 510(k) number is K242618.

When did Layer 7-T receive FDA 510(k) clearance?

Layer 7-T received FDA 510(k) clearance on 2025-03-30, under 510(k) number K242618.

Who is the listed applicant for Layer 7-T?

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

What is the FDA product code for Layer 7-T?

The FDA product code for Layer 7-T is GYC.

Related Devices (Code: GYC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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