FDA 510(k)

VPro5

K 號：K183018 · 2019-11-01

決定日期2019-11-01

產品代碼OYH

諮詢委員會DE

決定相當於

器材摘要

VPro5 is the device name listed in this FDA 510(k) record. The listed applicant is Propel Orthodontics, LLC. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K183018. The device is classified under product code OYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VPro5?

VPro5 is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Propel Orthodontics, LLC. The 510(k) number is K183018.

When did VPro5 receive FDA 510(k) clearance?

VPro5 received FDA 510(k) clearance on 2019-11-01, under 510(k) number K183018.

Who is the listed applicant for VPro5?

The FDA 510(k) record lists Propel Orthodontics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VPro5?

The FDA product code for VPro5 is OYH.

其他以 Propel Orthodontics, LLC 為申請人之記錄

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K172164PROPEL 裝置

相關器械（代碼：OYH）

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。

K170093AcceleDent OptimaOrthoaccel Technology, Inc.K153048AcceleDent AuraOrthoaccel Technologies, Inc.

官方來源

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