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FDA 510(k)

Tel-O-Graph

K 號:K173895 · 2019-05-16

決定日期2019-05-16
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Tel-O-Graph is the device name listed in this FDA 510(k) record. The listed applicant is I.E.M. Industrielle Entwicklung and Medizintechnik. It received FDA 510(k) clearance on 2019-05-16 under 510(k) number K173895. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tel-O-Graph?

Tel-O-Graph is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is I.E.M. Industrielle Entwicklung and Medizintechnik. The 510(k) number is K173895.

When did Tel-O-Graph receive FDA 510(k) clearance?

Tel-O-Graph received FDA 510(k) clearance on 2019-05-16, under 510(k) number K173895.

Who is the listed applicant for Tel-O-Graph?

The FDA 510(k) record lists I.E.M. Industrielle Entwicklung and Medizintechnik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tel-O-Graph?

The FDA product code for Tel-O-Graph is DXN.

相關臨床試驗

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相關器械(代碼:DXN)

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。

官方來源

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