FDA 510(k)

VALO 大型有線式

K 號：K190627 · 2019-04-29

決定日期2019-04-29

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

VALO Grand Corded 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 2019-04-29 under 510(k) number K190627. 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?

VALO Grand Corded is a medical device that received FDA 510(k) clearance on 2019-04-29. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K190627.

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

VALO Grand Corded received FDA 510(k) clearance on 2019-04-29, under 510(k) number K190627.

Who is the listed applicant for VALO Grand Corded?

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?

The FDA product code for VALO Grand Corded 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）

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