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FDA 510(k)

Cervella

K 號:K182311 · 2019-03-07

決定日期2019-03-07
產品代碼QJQ
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

Cervella is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Neurological Devices, LLC. It received FDA 510(k) clearance on 2019-03-07 under 510(k) number K182311. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cervella?

Cervella is a medical device that received FDA 510(k) clearance on 2019-03-07. The listed applicant is Innovative Neurological Devices, LLC. The 510(k) number is K182311.

When did Cervella receive FDA 510(k) clearance?

Cervella received FDA 510(k) clearance on 2019-03-07, under 510(k) number K182311.

Who is the listed applicant for Cervella?

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

What is the FDA product code for Cervella?

The FDA product code for Cervella is QJQ.

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相關器械(代碼:QJQ)

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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