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FDA 510(k)

神經頻率調節颅骨固定系統，NuCrani 板，KTC 髙溝蓋，DC 板

K 號：K192162 · 2020-03-13

申請人Neurovention, LLC
決定日期2020-03-13
產品代碼GXR
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

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate is the device name listed in this FDA 510(k) record. The listed applicant is Neurovention, LLC. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K192162. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate?

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is Neurovention, LLC. The 510(k) number is K192162.

When did NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate receive FDA 510(k) clearance?

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate received FDA 510(k) clearance on 2020-03-13, under 510(k) number K192162.

Who is the listed applicant for NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate?

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

What is the FDA product code for NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate?

The FDA product code for NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate is GXR.

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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。

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