FDA 510(k)

德米特拉 BDEM-01 皮膚顯微鏡

K 號：K192829 · 2019-12-13

決定日期2019-12-13

產品代碼PSN

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

Demetra BDEM-01 Dermatoscope is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192829. The device is classified under product code PSN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Demetra BDEM-01 Dermatoscope?

Demetra BDEM-01 Dermatoscope is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Barco N.V.. The 510(k) number is K192829.

When did Demetra BDEM-01 Dermatoscope receive FDA 510(k) clearance?

Demetra BDEM-01 Dermatoscope received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192829.

Who is the listed applicant for Demetra BDEM-01 Dermatoscope?

The FDA 510(k) record lists Barco N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Demetra BDEM-01 Dermatoscope?

The FDA product code for Demetra BDEM-01 Dermatoscope is PSN.

其他以 Barco N.V. 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。

K243307LCD 螢幕 (MDEC-2523)K242008Coronis OneLook K233693Nio Color 8MP (MDNC-8132)K230520Nio Color 2MP (MDNC-2521)；Nio Color 3MP (MDNC-3521)K213957德米特拉皮膚顯微鏡 BDEM-01 K203364MDPC-8127

查看所有 18 項裝置 →

相關器械（代碼：PSN）

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。

K230448DeepX 皮膚視覺皮膚鏡Deepx Health, LLC K213957德米特拉皮膚顯微鏡 BDEM-01Barco N.V.K201408德米特拉分析工具包Barco N.V.K180162VivaScope 系統Caliber Imaging & Diagnostics, Inc.

官方來源

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