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FDA 510(k)

Tempus LS - 手動版

K 號:K200849 · 2020-07-24

決定日期2020-07-24
產品代碼LDD
諮詢委員會履歷
決定相當於

器材摘要

Tempus LS - Manual is the device name listed in this FDA 510(k) record. The listed applicant is Remote Diagnostic Technologies, Ltd. A Philips Company. It received FDA 510(k) clearance on 2020-07-24 under 510(k) number K200849. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tempus LS - Manual?

Tempus LS - Manual is a medical device that received FDA 510(k) clearance on 2020-07-24. The listed applicant is Remote Diagnostic Technologies, Ltd. A Philips Company. The 510(k) number is K200849.

When did Tempus LS - Manual receive FDA 510(k) clearance?

Tempus LS - Manual received FDA 510(k) clearance on 2020-07-24, under 510(k) number K200849.

Who is the listed applicant for Tempus LS - Manual?

The FDA 510(k) record lists Remote Diagnostic Technologies, Ltd. A Philips Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tempus LS - Manual?

The FDA product code for Tempus LS - Manual is LDD.

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相關器械(代碼:LDD)

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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