FDA 510(k)

維特魯維安濾過泵

K 號：K170629 · 2017-06-22

決定日期2017-06-22

產品代碼QPB

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

VITRUVIAN INFILTRATION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Black & Black Surgical, Inc.. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K170629. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITRUVIAN INFILTRATION PUMP?

VITRUVIAN INFILTRATION PUMP is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Black & Black Surgical, Inc.. The 510(k) number is K170629.

When did VITRUVIAN INFILTRATION PUMP receive FDA 510(k) clearance?

VITRUVIAN INFILTRATION PUMP received FDA 510(k) clearance on 2017-06-22, under 510(k) number K170629.

Who is the listed applicant for VITRUVIAN INFILTRATION PUMP?

The FDA 510(k) record lists Black & Black Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITRUVIAN INFILTRATION PUMP?

The FDA product code for VITRUVIAN INFILTRATION PUMP is QPB.

其他以 Black & Black Surgical, Inc. 為申請人之記錄

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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相關器械（代碼：QPB）

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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官方來源

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