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FDA 510(k)

MAZIC Claro CAD 及 MAZIC Claro 壓力

K 號:K203672 · 2021-07-01

決定日期2021-07-01
產品代碼EIH
諮詢委員會DE
決定相當於

器材摘要

MAZIC Claro CAD and MAZIC Claro Press is the device name listed in this FDA 510(k) record. The listed applicant is Vericom Co., Ltd.. It received FDA 510(k) clearance on 2021-07-01 under 510(k) number K203672. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MAZIC Claro CAD and MAZIC Claro Press?

MAZIC Claro CAD and MAZIC Claro Press is a medical device that received FDA 510(k) clearance on 2021-07-01. The listed applicant is Vericom Co., Ltd.. The 510(k) number is K203672.

When did MAZIC Claro CAD and MAZIC Claro Press receive FDA 510(k) clearance?

MAZIC Claro CAD and MAZIC Claro Press received FDA 510(k) clearance on 2021-07-01, under 510(k) number K203672.

Who is the listed applicant for MAZIC Claro CAD and MAZIC Claro Press?

The FDA 510(k) record lists Vericom Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAZIC Claro CAD and MAZIC Claro Press?

The FDA product code for MAZIC Claro CAD and MAZIC Claro Press is EIH.

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其他以 Vericom Co., Ltd. 為申請人之記錄

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相關器械(代碼:EIH)

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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