FDA 510(k)

德米特拉皮膚顯微鏡 BDEM-01

K 號：K213957 · 2022-03-11

決定日期2022-03-11

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 Dermatoscope BDEM-01 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 2022-03-11 under 510(k) number K213957. 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 Dermatoscope BDEM-01?

Demetra Dermatoscope BDEM-01 is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Barco N.V.. The 510(k) number is K213957.

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

Demetra Dermatoscope BDEM-01 received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213957.

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

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 Dermatoscope BDEM-01?

The FDA product code for Demetra Dermatoscope BDEM-01 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)K203364MDPC-8127 K201408德米特拉分析工具包

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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 K201408德米特拉分析工具包Barco N.V.K192829德米特拉 BDEM-01 皮膚顯微鏡Barco N.V.K180162VivaScope 系統Caliber Imaging & Diagnostics, Inc.

官方來源

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