第7層-T
K 號:K242618 · 2025-03-30
廣告
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.
相關臨床試驗
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。
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。
K250094Atlas Stim Headbox (NK) (31-0601-0077);Atlas Stim Headbox (觸電防護) (31-0601-0089);Atlas Stim Headbox (HD) (31-0601-0132);ASHB 光纖雙工連接 2m (31-0204-0001);ASHB 光纖雙工連接 7m (31-0204-0002);ATLAS Stim Headbox 軟體 (36-0301-0006);Atlas Headbox 接口纜線 (NK) (31-0204-003);Atlas Headbox 接口纜線 (觸電防護) (31-0204-004);Atlas Headbox 接口纜線 (HD) (31-0204-005);Atlas Headbox 扩充面板 (31-0607-0014)Neuralynx, Inc.K221123智慧皮質條 (WCS)Wise S.R.L.K211954硬膜下電極,條/手術條,網/手術網,多條和分離網,手術映射網Spes Medica SrlK201931迪西醫療手術中硬膜下電極(條狀和網格)Dixi MedicalK191346Blackrock神經CoG硬膜下皮層電極(條狀和網格)Blackrock MicrosystemsK191186硬膜下條/手術中分離電極、硬膜下網/手術中網狀電極、雙面橫斷半球硬膜下電極、多條和縫隙網狀硬膜下電極、手術中定位網狀硬膜下電極Ad-Tech Medical Instrument Corporation
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。
廣告