FDA 510(k)

VALO 大型有線及配件鏡頭

K 號：K210550 · 2021-03-01

決定日期2021-03-01

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

VALO Grand Corded and Accessory Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K210550. 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 VALO Grand Corded and Accessory Lenses?

VALO Grand Corded and Accessory Lenses is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K210550.

When did VALO Grand Corded and Accessory Lenses receive FDA 510(k) clearance?

VALO Grand Corded and Accessory Lenses received FDA 510(k) clearance on 2021-03-01, under 510(k) number K210550.

Who is the listed applicant for VALO Grand Corded and Accessory Lenses?

The FDA 510(k) record lists Ultradent Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALO Grand Corded and Accessory Lenses?

The FDA product code for VALO Grand Corded and Accessory Lenses is EBZ.

其他以 Ultradent Products, Inc. 為申請人之記錄

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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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