FDA 510(k)

Cybird 體外LED固化燈

K 號：K191221 · 2020-01-10

決定日期2020-01-10

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

Cybird LED Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Dxm Co., Ltd.. It received FDA 510(k) clearance on 2020-01-10 under 510(k) number K191221. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cybird LED Curing Light?

Cybird LED Curing Light is a medical device that received FDA 510(k) clearance on 2020-01-10. The listed applicant is Dxm Co., Ltd.. The 510(k) number is K191221.

When did Cybird LED Curing Light receive FDA 510(k) clearance?

Cybird LED Curing Light received FDA 510(k) clearance on 2020-01-10, under 510(k) number K191221.

Who is the listed applicant for Cybird LED Curing Light?

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

What is the FDA product code for Cybird LED Curing Light?

The FDA product code for Cybird LED Curing Light is EBZ.

其他以 Dxm Co., Ltd. 為申請人之記錄

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K173876Cybird 體外LED固化燈

相關器械（代碼：EBZ）

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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