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FDA 510(k)

第7層-T

K 號:K242618 · 2025-03-30

決定日期2025-03-30
產品代碼GYC
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

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.

常見問題

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.

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相關器械(代碼:GYC)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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