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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 a medical device manufactured by Precision Neuroscience, Corp.. It received FDA 510(k) clearance on 2025-03-30 under approval 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. It is manufactured by Precision Neuroscience, Corp.. The 510(k) number is K242618.

When was Layer 7-T approved by the FDA?

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

What company makes Layer 7-T?

Layer 7-T is manufactured by Precision Neuroscience, Corp..

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

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

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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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