免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

無限 / 無限橫向彈性牙科系統

K 號:K180935 · 2020-02-05

決定日期2020-02-05
產品代碼EIA
諮詢委員會DE
決定相當於

器材摘要

Infinity / Infinity Cross Flex Dental Systems is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Industria E Comercio S.A.. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K180935. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Infinity / Infinity Cross Flex Dental Systems?

Infinity / Infinity Cross Flex Dental Systems is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Olsen Industria E Comercio S.A.. The 510(k) number is K180935.

When did Infinity / Infinity Cross Flex Dental Systems receive FDA 510(k) clearance?

Infinity / Infinity Cross Flex Dental Systems received FDA 510(k) clearance on 2020-02-05, under 510(k) number K180935.

Who is the listed applicant for Infinity / Infinity Cross Flex Dental Systems?

The FDA 510(k) record lists Olsen Industria E Comercio S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infinity / Infinity Cross Flex Dental Systems?

The FDA product code for Infinity / Infinity Cross Flex Dental Systems is EIA.

相關臨床試驗

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。

相關器械(代碼:EIA)

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑