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FDA 510(k)

EZstim*III 頸外周神經刺激器/神經定位器

K 號:K162048 · 2016-12-05

決定日期2016-12-05
產品代碼KOI
諮詢委員會AN
決定相當於

器材摘要

EZstim*III Peripheral Nerve Stimulator/Nerve Locator is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health - Irvine. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K162048. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

EZstim*III Peripheral Nerve Stimulator/Nerve Locator is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Halyard Health - Irvine. The 510(k) number is K162048.

When did EZstim*III Peripheral Nerve Stimulator/Nerve Locator receive FDA 510(k) clearance?

EZstim*III Peripheral Nerve Stimulator/Nerve Locator received FDA 510(k) clearance on 2016-12-05, under 510(k) number K162048.

Who is the listed applicant for EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

The FDA 510(k) record lists Halyard Health - Irvine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

The FDA product code for EZstim*III Peripheral Nerve Stimulator/Nerve Locator is KOI.

相關臨床試驗

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相關器械(代碼:KOI)

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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