FDA 510(k)

康科德模型 Concorde US 及 Concorde ST 轟軟組織活體組織切片設備

K 號：K201244 · 2020-08-07

決定日期2020-08-07

產品代碼KNW

諮詢委員會GU

決定相當於

器材摘要

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is the device name listed in this FDA 510(k) record. The listed applicant is Transmed7, LLC. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K201244. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Transmed7, LLC. The 510(k) number is K201244.

When did Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices receive FDA 510(k) clearance?

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices received FDA 510(k) clearance on 2020-08-07, under 510(k) number K201244.

Who is the listed applicant for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

The FDA 510(k) record lists Transmed7, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

The FDA product code for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is KNW.

其他以 Transmed7, LLC 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：KNW）

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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