FDA 510(k)

SignalMark 乳癌標記器

K 號：K190689 · 2019-08-14

決定日期2019-08-14

產品代碼NEU

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

SignalMark Breast Marker is the device name listed in this FDA 510(k) record. The listed applicant is View Point Medical, Inc.. It received FDA 510(k) clearance on 2019-08-14 under 510(k) number K190689. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SignalMark Breast Marker?

SignalMark Breast Marker is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is View Point Medical, Inc.. The 510(k) number is K190689.

When did SignalMark Breast Marker receive FDA 510(k) clearance?

SignalMark Breast Marker received FDA 510(k) clearance on 2019-08-14, under 510(k) number K190689.

Who is the listed applicant for SignalMark Breast Marker?

The FDA 510(k) record lists View Point Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SignalMark Breast Marker?

The FDA product code for SignalMark Breast Marker is NEU.

其他以 View Point Medical, 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。

K180175SignalMark 肺穿刺點標記器

相關器械（代碼：NEU）

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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