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FDA 510(k)

ZIIP設備

K 號:K161484 · 2017-02-24

申請人Ziip,Llc
決定日期2017-02-24
產品代碼NFO
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

ZIIP Device is the device name listed in this FDA 510(k) record. The listed applicant is Ziip,Llc. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K161484. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ZIIP Device?

ZIIP Device is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Ziip,Llc. The 510(k) number is K161484.

When did ZIIP Device receive FDA 510(k) clearance?

ZIIP Device received FDA 510(k) clearance on 2017-02-24, under 510(k) number K161484.

Who is the listed applicant for ZIIP Device?

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

What is the FDA product code for ZIIP Device?

The FDA product code for ZIIP Device is NFO.

相關臨床試驗

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相關器械(代碼:NFO)

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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