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FDA 510(k)

Longeviti 清適頭蓋植入體

K 號:K203349 · 2020-12-16

決定日期2020-12-16
產品代碼GXN
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

Longeviti ClearFit Cranial Implant is the device name listed in this FDA 510(k) record. The listed applicant is Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2020-12-16 under 510(k) number K203349. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Longeviti ClearFit Cranial Implant?

Longeviti ClearFit Cranial Implant is a medical device that received FDA 510(k) clearance on 2020-12-16. The listed applicant is Longeviti Neuro Solutions, LLC. The 510(k) number is K203349.

When did Longeviti ClearFit Cranial Implant receive FDA 510(k) clearance?

Longeviti ClearFit Cranial Implant received FDA 510(k) clearance on 2020-12-16, under 510(k) number K203349.

Who is the listed applicant for Longeviti ClearFit Cranial Implant?

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

What is the FDA product code for Longeviti ClearFit Cranial Implant?

The FDA product code for Longeviti ClearFit Cranial Implant is GXN.

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其他以 Longeviti Neuro Solutions, LLC 為申請人之記錄

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相關器械(代碼:GXN)

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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